Resources

Resource Files – General

Clinical Papers
  • Outcome after procedures for retained blood syndrome in coronary surgery

    A total of 2764 consecutive patients who underwent isolated CABG from 2006 to 2013 were investigated retrospectively. Conclusion was that patients requiring any procedure for blood removal from pericardial and pleural spaces is associated with an increased risk of severe complications after isolated CABG. (Tauriainen, 2017)

    Updated: April 17, 2017

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    Outcome after procedures for retained blood syndrome in coronary surgery
    http://www.clearflow.com/resources/?upf=dl&id=635
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • Impact of Retained Blood Requiring Reintervention on Outcomes After Cardiac Surgery

    Study published in Journal of Thoracic and Cardiovascular Surgery which reviewed patient complications in pleural and pericardial cavities after cardiac surgery. Found statistically significant increases in mortality, hospital and ICU LOS, time of ventilation, and incidence of hemolysis in patients with retained blood interventions due to incomplete evacuation of shed blood. (Balzer, 2016)

    Updated: April 17, 2017

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    Impact of Retained Blood Requiring Reintervention on Outcomes After Cardiac Surgery
    http://www.clearflow.com/resources/?upf=dl&id=632
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • Systematic review and meta-analysis of randomized controlled trials assessing safety and efficacy of posterior pericardial drainage in patients undergoing heart surgery

    Review of 19 randomized controlled trials published in the Journal of Thoracic and Cardiovascular Surgery. Showed post pericardial drainage is safe and effective technique associated with a reduction in tamponade, early and late pericardial effusions, POAF and hospital stay. (Gozdek, 2016)

    Updated: April 17, 2017

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    Systematic review and meta-analysis of randomized controlled trials assessing safety and efficacy of posterior pericardial drainage in patients undergoing heart surgery
    http://www.clearflow.com/resources/?upf=dl&id=631
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • Tamponade Relief by Active Clearance of Chest Tubes

    This is a case report of a patient who developed a tamponade in the ICU while recovering from heart surgery. The tamponade was recognized, and captured on Echo imaging. The patient had a PleuraFlow, so they actuated it a few times, and a clot was removed, and a gush of blood drained. The patient’s condition greatly improved, and the tamponade disappeared on Echo. (Vistarini, 2016)

    Updated: April 17, 2017

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    Tamponade Relief by Active Clearance of Chest Tubes
    http://www.clearflow.com/resources/?upf=dl&id=571
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • Retained Blood Syndrome After Cardiac Surgery: A New Look at an Old Problem

    Retained post surgical blood, known as Retained Blood Syndrome (RBS), occurs in 1 in 5 patients and results in the need for invasive post-op re-interventions for tamponade and/or hemothorax in the acute setting, pericardial and/or pleural effusions subacutely, or fibrosis in the chronic setting. (Boyle. 2015)

    Updated: January 3, 2016

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    Retained Blood Syndrome After Cardiac Surgery: A New Look at an Old Problem
    http://www.clearflow.com/resources/?upf=dl&id=533
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • Active clearance of chest drainage catheters reduces retained blood

    Active tube clearance reduces interventions for retained blood syndrome and postoperative atrial fibrillation, underscoring the importance of maintaining chest tube patency after cardiac surgery. (Sirch. 2015)

    Updated: January 3, 2016

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    Active clearance of chest drainage catheters reduces retained blood
    http://www.clearflow.com/resources/?upf=dl&id=532
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • Hemoglobin-associated oxidative stress in the pericardial compartment of postoperative cardiac surgery patients

    Study that showed that retained blood in the pericardium leads to an intense, local pro-oxidant, pro-inflammatory response that may damage the pericardial environment and contribute to the development of POAF. (Kramer.2015)

    Updated: April 17, 2017

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    Hemoglobin-associated oxidative stress in the pericardial compartment of postoperative cardiac surgery patients
    http://www.clearflow.com/resources/?upf=dl&id=629
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • Superior Chest Drainage With an Active Tube Clearance System

    Evaluation of a Downsized Chest Tube, published in The Annals of Thoracic Surgery (Arakawa. 2010)

    Updated: February 13, 2015

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    Superior Chest Drainage With an Active Tube Clearance System
    http://www.clearflow.com/resources/?upf=dl&id=305
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • To Strip or Not to Strip?

    To Strip or Not to Strip? Physiological Effects of Chest Tube Manipulation, published in the American Journal of Critical Care (Halm. 2007)

    Updated: February 13, 2015

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    To Strip or Not to Strip?
    http://www.clearflow.com/resources/?upf=dl&id=301
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • Incidence of chest tube clogging after cardiac surgery

    Incidence of chest tube clogging after cardiac surgery: a single-centre prospective observational study, published in the European Journal of Cardio-Thoracic Surgery (Karimov. 2013)

    Updated: February 13, 2015

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    Incidence of chest tube clogging after cardiac surgery
    http://www.clearflow.com/resources/?upf=dl&id=300
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • Prevalence and Clinical Course of Pleural Effusions at 30 Days after Coronary Artery and Cardiac Surgery

    Prevalence and Clinical Course of Pleural Effusions at 30 Days after Coronary Artery and Cardiac Surgery, published in the American Journal of Respiratory and Critical Care Medicine (Light. 2002)

    Updated: February 13, 2015

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    Prevalence and Clinical Course of Pleural Effusions at 30 Days after Coronary Artery and Cardiac Surgery
    http://www.clearflow.com/resources/?upf=dl&id=299
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • The PleuraFlow Active Chest Tube Clearance System Initial Clinical Experience in Adult Cardiac Surgery

    The PleuraFlow Active Chest Tube Clearance System Initial Clinical Experience in Adult Cardiac Surgery, published in the International Society for Minimally Invasive Cardiothoracic Surgery (Perrault. 2012)

    Updated: February 13, 2015

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    The PleuraFlow Active Chest Tube Clearance System Initial Clinical Experience in Adult Cardiac Surgery
    http://www.clearflow.com/resources/?upf=dl&id=298
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • Chest Tube Selection in Cardiac and Thoracic Surgery

    Chest Tube Selection in Cardiac and Thoracic Surgery: A Survey of Chest Tube-Related Complications and Their Management (Shalli. 2009)

    Updated: February 13, 2015

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    Chest Tube Selection in Cardiac and Thoracic Surgery
    http://www.clearflow.com/resources/?upf=dl&id=297
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • Improved drainage with active chest tube clearance

    Improved drainage with active chest tube clearance, published in Interactive CardioVascular and Thoracic Surgery (Shiose. 2010)

    Updated: February 13, 2015

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    Improved drainage with active chest tube clearance
    http://www.clearflow.com/resources/?upf=dl&id=296
    Username: ClearFlow | Password: ACT (case-sensitive)
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Clinical Posters
  • Costs Associated With Complications of Retained Blood in Cardiac Surgery

    Presented at American Society of Anesthesiologists, San Diego, CA. October, 2015. Data from 3,184 patients was included in the analysis from Charité–Universitätsmedizin in Berlin, Germany. RBS was found in 17% of all cardiac surgery patients. Median of total costs was $38,970 (35,264 Euros) in patients with RBS interventions compared to $16,376 (14,888 Euros) in patients with no RBS interventions. Statistically significant negative outcomes were noted with patients in the RBS group for Mortality, Length of Stay (both hospital and ICU), ventilator time, and incidence of hemodialysis.

    Updated: March 19, 2017

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    Costs Associated With Complications of Retained Blood in Cardiac Surgery
    http://www.clearflow.com/resources/?upf=dl&id=625
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • ACT: An Effective Drainage System to Prevent POAF

    Presentation at 2016 International Society for Minimally Invasive Cardiothoracic Surgery (ISMICS) Meeting showed patients treated with PleuraFlow ACT had reduced POAF (20%) and shorter length of stay (5 days) versus patients without ACT (36% POAF and 6 days length of stay).

    Updated: August 9, 2016

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    ACT: An Effective Drainage System to Prevent POAF
    http://www.clearflow.com/resources/?upf=dl&id=589
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • Postoperative Infections are Associated with Retained Blood after Cardiac Surgery

    Presentation at 2016 Society of Cardiovascular Anesthesiologists Meeting showed patients with retained blood interventions (19%; n=6,909) had increased overall infection rate (from 4% to 16%); increased pneumonia from 1% to 9%; increased sepsis from 1% to 7%; and statistically significant increases in C diff, superficial wound, deep wound, and UTI infections.

    Updated: August 9, 2016

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    Postoperative Infections are Associated with Retained Blood after Cardiac Surgery
    http://www.clearflow.com/resources/?upf=dl&id=572
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • Impact of Drain Retained Blood on Outcome after Cardiac Surgery

    Impact of Drain Retained Blood on Outcome after Cardiac Surgery, published at Charité Universitätsmedizin Berlin, Department of Anesthesiology and Intensive Care Medicine, Berlin, Germany (Balzer. 2015)

    Updated: August 9, 2016

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    Impact of Drain Retained Blood on Outcome after Cardiac Surgery
    http://www.clearflow.com/resources/?upf=dl&id=385
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • Retained Blood Syndrome (RBS) After Cardiac Surgery – Clinical and Cost Implications

    Retained Blood Syndrome (RBS) is the composite of complications after cardiothoracic surgery, including hemothorax, pericardial tamponade, bloody pleural or pericardial effusions. Measurable RBS Complications, Additional Complications, and Costs implications for the hospital are reviewed.

    Updated: January 9, 2017

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    Retained Blood Syndrome (RBS) After Cardiac Surgery – Clinical and Cost Implications
    http://www.clearflow.com/resources/?upf=dl&id=590
    Username: ClearFlow | Password: ACT (case-sensitive)
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Active Clearance Series
  • Active Clearance of Chest Tubes Reduces Re-Exploration for Bleeding After Ventricular Assist Device Implantation

    Prospective observational study from the Mayo Clinic that looked at results from 252 LVAD patients. Showed that active clearance of chest drains appears to reduce the incidence of retained blood syndrome (RBS) interventions after LVAD implantation surgery. (Maltais, 2016)

    Updated: April 17, 2017

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    Active Clearance of Chest Tubes Reduces Re-Exploration for Bleeding After Ventricular Assist Device Implantation
    http://www.clearflow.com/resources/?upf=dl&id=638
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • Active Clearance Series #1

    Clearing the misconceptions about chest tube clogging. Yes, it’s serious. Chest tubes clog after cardiac surgery. That’s a fact acknowledged by 100% of surgeons and ICU nurses surveyed. But what is the actual incidence of clogging and what are we doing about its associated adverse complications? A new prospective study from Cleveland Clinic sheds new light into the damaging prevalence of chest tube clogging and demonstrates the need for new technology and programs to help fight it.

    Updated: December 5, 2016

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    Active Clearance Series #1
    http://www.clearflow.com/resources/?upf=dl&id=295
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • Active Clearance Series #2

    Three practices to speed patient recovery after ventricular assist device (VAD) implantation. By implementing a few simple but crucial protocols, you can greatly speed recovery, lower the costs of care, and ensure optimal outcomes for your patient.

    Updated: February 14, 2015

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    Active Clearance Series #2
    http://www.clearflow.com/resources/?upf=dl&id=294
    Username: ClearFlow | Password: ACT (case-sensitive)
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Brochure
Videos
Presentations
Continuous Quality Improvement (CQI) Program
Post-operative Atrial Fibrillation (POAF)
  • POAF Focus Sell Sheet

    This sell sheet describes how chest tube clogging can lead to Retained Blood Syndrome (RBS) which can trigger Postoperative Atrial Fibrillation (POAF).  

    Updated: December 5, 2016

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    POAF Focus Sell Sheet
    http://www.clearflow.com/resources/?upf=dl&id=552
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • POAF Focus Poster

    This poster describes how chest tube clogging can lead to Retained Blood Syndrome (RBS) which can trigger Postoperative Atrial Fibrillation (POAF).

    Updated: December 5, 2016

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    POAF Focus Poster
    http://www.clearflow.com/resources/?upf=dl&id=551
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • Hemoglobin-associated oxidative stress in the pericardial compartment of postoperative cardiac surgery patients

    Patients who have post-operative AFib after surgery have significantly increased oxidative stress, which may be triggered by a number of things, including retained blood in the chest.

    Updated: April 7, 2016

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    Hemoglobin-associated oxidative stress in the pericardial compartment of postoperative cardiac surgery patients
    http://www.clearflow.com/resources/?upf=dl&id=574
    Username: ClearFlow | Password: ACT (case-sensitive)
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Economic Information and Calculator
  • Cost of Retained Blood Syndrome Interventions Calculator

    This tool will help you calculate the cost of Retained Blood Syndrome Interventions. Instructions for how to use the worksheet are on the first tab.  On the second tab, insert the hospital name, number of procedures per year, and number of PleuraFlows used per case to calculate the estimated cost of Retained Blood Syndrome Interventions.

    Updated: April 16, 2015

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    Cost of Retained Blood Syndrome Interventions Calculator
    http://www.clearflow.com/resources/?upf=dl&id=313
    Username: ClearFlow | Password: ACT (case-sensitive)
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Media Kit
ACT Registry Files
  • ACT Registry Summary

    ACT Registry Summary PleuraFlow® Active Clearance Technology™ System The ACT Registry – Prevention of Retained-Blood Outcomes with Active Clearance Technology is a multinational registry of cardiothoracic surgery patients.

    Updated: March 4, 2015

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    ACT Registry Summary
    http://www.clearflow.com/resources/?upf=dl&id=287
    Username: ClearFlow | Password: ACT (case-sensitive)
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Regulatory and Governance
  • 510(k) for FlowGlide System

    Letter from FDA dated November, 30 2016 with 510(k) Letter, Summary, and Indications for Use.

    Updated: January 5, 2017

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    510(k) for FlowGlide System
    http://www.clearflow.com/resources/?upf=dl&id=604
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • 510(k) for PleuraFlow System

    Letter from FDA dated January 20, 2016 with 510(k) Letter, Summary, and Indications for Use.

    Updated: January 5, 2017

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    510(k) for PleuraFlow System
    http://www.clearflow.com/resources/?upf=dl&id=603
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • Certificato Cofepris

    PleuraFlow registration for Mexico. Expires 2020.

    Updated: January 30, 2017

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    Certificato Cofepris
    http://www.clearflow.com/resources/?upf=dl&id=618
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • Declaration of Conformity – EU

    Declaration of Conformity from June 6, 2016 for the European Union.

    Updated: January 5, 2017

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    Declaration of Conformity – EU
    http://www.clearflow.com/resources/?upf=dl&id=605
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • CE Quality System Certificate from NSAI

    CE Quality System Approval Certificate from NSAI for the PleuraFlow System through June, 2019.

    Updated: January 5, 2017

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    CE Quality System Certificate from NSAI
    http://www.clearflow.com/resources/?upf=dl&id=316
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • Health Canada Clearance Medical Device License

    Health Canada Clearance Medical Device License

    Updated: January 5, 2017

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    Health Canada Clearance Medical Device License
    http://www.clearflow.com/resources/?upf=dl&id=315
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • Australian Register of Therapeutic Goods Certificate

    Australian Register of Therapeutic Goods Certificate

    Updated: January 5, 2017

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    Australian Register of Therapeutic Goods Certificate
    http://www.clearflow.com/resources/?upf=dl&id=314
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • Certificate of Liability Insurance Exp 1.11.2018

    ClearFlow Certificate of Liability Insurance 2017

    Updated: January 29, 2017

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    Certificate of Liability Insurance Exp 1.11.2018
    http://www.clearflow.com/resources/?upf=dl&id=345
    Username: ClearFlow | Password: ACT (case-sensitive)
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Instructions for Use

Clinical Support – Customer Files

Clinical Training Files
  • Clinical Training Module for OR and ICU

    Clinical Training Module: PleuraFlow® Active Clearance Technology™ (ACT) System

    Updated: April 17, 2017

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    Clinical Training Module for OR and ICU
    http://www.clearflow.com/resources/?upf=dl&id=319
    Username: ClearFlow | Password: ACT (case-sensitive)
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ICU Poster, Actuation Schedule, Quick Reference Guide
  • Recommended Actuation Schedule

    Recommended Actuation Schedule PleuraFlow® System with Active Clearance Technology® (ACT™)

    Updated: January 13, 2017

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    Recommended Actuation Schedule
    http://www.clearflow.com/resources/?upf=dl&id=330
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • Quick Reference Guide

    How to Operate the PleuraFlow® ACT™ System and Maintain Chest Tube Patency

    Updated: January 5, 2017

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    Quick Reference Guide
    http://www.clearflow.com/resources/?upf=dl&id=329
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • ICU Poster

    Maintaining Chest Tube Patency After Cardiac Surgery with the PleuraFlow® Active Clearance Technology® (ACT™) System

    Updated: December 5, 2016

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    ICU Poster
    http://www.clearflow.com/resources/?upf=dl&id=328
    Username: ClearFlow | Password: ACT (case-sensitive)
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Technical Tips Video Series
Clinical Use Protocols
  • Clinical Use Protocol 003

    Protocol for Active Clearance of Anterior Mediastinal and Pleural Chest Tubes to Maintain Tube Patency After VAD Surgery

    Updated: September 2, 2015

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    Clinical Use Protocol 003
    http://www.clearflow.com/resources/?upf=dl&id=321
    Username: ClearFlow | Password: ACT (case-sensitive)
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  • Clinical Use Protocol 001

    Protocol for Active Clearance of Anterior Mediastinal Chest Tubes to Maintain Tube Patency After Cardiac Surgery

    Updated: September 2, 2015

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    Clinical Use Protocol 001
    http://www.clearflow.com/resources/?upf=dl&id=322
    Username: ClearFlow | Password: ACT (case-sensitive)
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Product Complaints
Forms and Links to Product User Surveys
  • User Feedback Survey for ICU Personnel

    The purpose of this brief survey is to collect valuable information about the PleuraFlow® System from a range of healthcare practitioners who use the device on an ongoing basis. This information helps ClearFlow, Inc. learn about the real life performance of the device and assess opportunities for product improvements. This survey is part of ClearFlow, Inc. Quality System and regulatory requirements. The information you provide will be anonymized and will remain confidential. It will be used internally for the purposes described above. If requested, data summaries may be shared with US (FDA) and OUS Regulatory agencies. It should take 2-4 minutes to complete. Link to survey:  https://www.surveymonkey.com/s/6YYN8X3  

    Updated: September 17, 2015

    Download
  • User Feedback Survey for O.R. Personnel

    The purpose of this brief survey is to collect valuable information about the PleuraFlow® System from a range of healthcare practitioners who use the device on an ongoing basis. This information helps ClearFlow, Inc. learn about the real life performance of the device and assess opportunities for product improvements. This survey is part of ClearFlow, Inc. Quality System and regulatory requirements. The information you provide will be anonymized and will remain confidential. It will be used internally for the purposes described above. If requested, data summaries may be shared with US (FDA) and OUS Regulatory agencies. It should take 2-4 minutes to complete. Please copy and paste the following link to your browser: https://www.surveymonkey.com/r/?sm=T8ZAnglrmrntY83D29IXVg%3d%3d  

    Updated: September 17, 2015

    Download
  • Clinical Training Sign-In Sheet

    Clinical Training Sign-In Sheet

    Updated: January 13, 2017

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    Clinical Training Sign-In Sheet
    http://www.clearflow.com/resources/?upf=dl&id=339
    Username: ClearFlow | Password: ACT (case-sensitive)
    ×