BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERMANENT LIFE SUPPORT SET

    MDR report key: 4619333 · Received March 18, 2015

    Report

    Report Number
    8010762-2015-00233
    Event Type
    Death
    Date Received
    March 18, 2015
    Date of Event
    February 18, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    KFM
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT. SIMILAR PRODUCTS, SHOWING A SIMILAR MALFUNCTION, HAVE BEEN TESTED AND UNDER OPTICAL MICROSCOPE DELAMINATION OF SOME GAS FIBERS WERE OBSERVED. HENCE, THE PRIMING SOLUTION OR BLOOD WAS ABLE TO FLOW INSIDE THE GAP BETWEEN THE GAS FIBERS AND POLYURETHANE AND THE GRAVITY GUIDED IT TO THE GAS EXITING PATH ALONG THE HOUSING. THE MANUFACTURER INITIATED A CUSTOMER NOTIFICATION CONCERNING THE PROBLEM, THE POTENTIAL RISK AND THE RECOMMENDED HANDLING IN THE EVENT THIS FAILURE OCCURS (FSCA# (B)(4)). THE INVESTIGATION UNDER CAPA PROCESS (CAPA (B)(4)) HAS IDENTIFIED THAT THE ROOT CAUSE IS DUE TO THE MANUFACTURING PROCESS OF THE RAW MATERIAL FIBERS USED IN THE OXYGENATOR. IF, DURING THE SURFACE PRE-TREATMENT, A SYSTEM MALFUNCTION RESULTS IN A SYSTEM STOP, THE ENTIRE LENGTH OF THE FIBER IS NOT PROPERLY TREATED TO MODIFY THE SURFACE TENSION. IF THESE UNTREATED FIBERS ARE PRESENT IN THE EPOXY AREA OF THE OXYGENATOR, IT IS NOT PROPERLY FIXED IN THE EPOXY. WHEN THIS OCCURS, THE FIBERS ARE ABLE TO "SHRINK OUT" OF THE EPOXY AND RESULT IN THE REPORTED LEAKAGE. THE RAW MATERIAL MANUFACTURER HAS INITIATED STEPS TO REPEAT THE SURFACE PRE-TREATMENT TO ENSURE THAT THE PROPER SURFACE TENSION IS PRESENT ON THE ENTIRE LENGTH OF THE FIBERS. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED UNDER SECTION D IS NOT DISTRIBUTED TO THE US, BUT THE PRODUCT WITH CONTRIBUTING DESIGN FUNCTION TO THE AFFECTED COMPONENT (QUADROX-ID) IS REGISTERED UNDER 510(K): K101153.

    Description of Event or Problem · 1

    DESCRIPTION FROM THE CUSTOMER REPORT: A BLOOD LEAKAGE WAS NOTICED AT THE GAS OUTLET OF THE OXYGENATOR 2 HOURS AFTER PUTTING IN PLACE THE SET. ACTIONS TAKEN: MONITORING AND REPLACEMENT OF THE SET WILL BE DONE WHEN THE PATIENT IS STABLE. ADDITIONAL INFO RECEIVED ON 02/23/2015: NO CLINICAL CONSEQUENCE DUE TO THE EVENT WAS REPORTED. THE PATIENT DIED BUT THE CUSTOMER STATED THAT THERE WAS NO LINK BETWEEN THE DEATH OF THE PATIENT AND THE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185486 PERMANENT LIFE SUPPORT SET BE-PLS 2050#PERMANENT LIFE SUPPORT SET KFM MAQUET CARDIOPULMONARY AG BE-PLS 2050 70100002

    Patients

    Seq Age Sex Outcome Treatment
    1 Death