BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXYGENATOR, CARDIOPULMONARY BYPASS

    MDR report key: 4877664 · Received June 26, 2015

    Report

    Report Number
    8010762-2015-00766
    Event Type
    Injury
    Date Received
    June 26, 2015
    Date of Event
    June 19, 2015
    Report Date
    April 30, 2020
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY AG IS AWARE OF SIMILAR COMPLAINTS SHOWING A SIMILAR MALFUNCTION AND AN INTERNAL PROCESS ((B)(4)) WAS INITIATED TO DETERMINE THE MOST PROBABLE ROOT CAUSE AND TO IMPLEMENT THE APPROPRIATE CORRECTIVE ACTION. DUE TO THIS NO FURTHER ACTION WILL BE COMPLETED AT THIS TIME. THIS DATA IS BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRACKING AND TRENDING PROCESS. ABBREVIATION NC: NONCONFORMANCE. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED UNDER SECTION D IS A TUBING SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-I WHICH IS REGISTERED UNDER 510(K): K082117.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DETERMINED SO FAR THAT THE DE-AIRING MEMBRANE BECOMES PERMEABLE FOR FLUIDS (PRIMING SOLUTION / BLOOD) . THE INVESTIGATED CUSTOMER COMPLAINTS SHOWED NONCONFORMING AREAS IN THE MEMBRANE BODY AS WELL AS WEEK BONDING BETWEEN THE MEMBRANE AND OXYGENATOR AS MOST PROBABLE CAUSE. THEREFORE MAQUET CARDIOPULMONARY (B)(4) HAS INITIATED A CAPA PROCESS (B)(4) TO ADDRESS THE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTION. DETERMINING THE ROOT CAUSE IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AS SOON AS FURTHER INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). RESULT OF THE ROOT CAUSE ANALYSIS MEANWHILE THE ROOT CAUSE IS IDENTIFIED. INVESTIGATIONS COULD PROVE THAT THE INTRODUCTION OF THE NEW GLUE FOR ADULT AND SMALL ADULT OXYGENATORS AT THE BEGINNING OF 2013 - IS NOT RESPONSIBLE FOR THE INCREASED LEAKAGE OF DE-AIRING CONNECTORS. THE ROOT CAUSE COMPRISES THE FOLLOWING THREE SUB ITEMS: -THE LAMINATED PTFE MEMBRANE SHOWS QUALITATIVE DIFFERENCES WITHIN THE LOT DUE TO THE SIZE OF THE PRODUCTION LOT (MINIMUM 1850 FEET X 11.25 INCH) AND THE PACKAGING OF THE ROLLS. -THE FUNCTIONAL PTFE MEMBRANE IS VERY SENSITIVE TO MECHANICAL STRESS. THEREFORE THE HITHERTO EXISTING INSTRUCTIONS IN BOP (BASIC OPERATION PROCEDURE) 714 FOR PUNCHING AND BOP 715 FOR WELDING THE DE-AIRING MEMBRANE WILL BE ADJUSTED. -THE SOFTLINE COATING AND THE PRESSURE TEST OF OXYGENATORS TAKES PLACE SIMULTANEOUSLY AT 1.1 BAR. THE HYDROPHOBIC CHARACTER OF THE MEMBRANE IS CHANGED BY DINT OF THE HYDROPHILIC SOFTLINE COATING SOLUTION, WHICH ENTERS INTO THE PTFE MEMBRANE

    Additional Manufacturer Narrative · 1

    (B)(4). RESULT OF THE ROOT CAUSE ANALYSIS: MEANWHILE THE ROOT CAUSE IS IDENTIFIED. INVESTIGATIONS COULD PROVE THAT THE INTRODUCTION OF THE NEW GLUE FOR ADULT AND SMALL ADULT OXYGENATORS AT THE BEGINNING OF 2013 - GUESS OF THE PRECEDING (B)(4)- IS NOT RESPONSIBLE FOR THE INCREASED LEAKAGE OF DE-AIRING CONNECTORS. THE ROOT CAUSE COMPRISES THE FOLLOWING THREE SUB ITEMS: -THE LAMINATED PTFE MEMBRANE SHOWS QUALITATIVE DIFFERENCES WITHIN THE LOT DUE TO THE SIZE OF THE PRODUCTION LOT (MINIMUM 1850 FEET X 11.25 INCH) AND THE PACKAGING OF THE ROLLS. -THE FUNCTIONAL PTFE MEMBRANE IS VERY SENSITIVE TO MECHANICAL STRESS. THEREFORE THE HITHERTO EXISTING INSTRUCTIONS IN BOP (BASIC OPERATION PROCEDURE) 714 FOR PUNCHING AND BOP 715 FOR WELDING THE DE-AIRING MEMBRANE WILL BE ADJUSTED. -THE SOFTLINE COATING AND THE PRESSURE TEST OF OXYGENATORS TAKES PLACE SIMULTANEOUSLY AT 1.1 BAR. THE HYDROPHOBIC CHARACTER OF THE MEMBRANE IS CHANGED BY DINT OF THE HYDROPHILIC SOFTLINE COATING SOLUTION, WHICH ENTERS INTO THE PTFE MEMBRANE

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER: "A DROP FLUID WAS NOTED FROM DE-AIRING MEMBRANE AFTER CARDIOPULMONARY BYPASS, THE PRODUCT WAS STILL IN USE." (B)(4).

    Description of Event or Problem · 1

    (B)(4). INITIAL REPORT WAS SUBMITTED ON PAPER JUNE 29,2015 UNDER MFR REPORT # 8010762-2015-00766. THEN FOLLOW-UP # 1 WAS SUBMITTED ON PAPER OCTOBER 5,2015 ALSO UNDER MFR REPORT # 8010762-2015-00766. FOLLOW-UP # 2 WAS SUBMITTED ELECTRONICALLY ON MARCH 18,2016 UNDER A ERRONEOUS MFR REPORT # 8010762-2016-00193.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414352 OXYGENATOR, CARDIOPULMONARY BYPASS OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG VKMO 78000 92145942

    Patients

    Seq Age Sex Outcome Treatment
    1 Other