BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BE-PLS 2050

    MDR report key: 3720746 · Received February 25, 2014

    Report

    Report Number
    8010762-2014-00077
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    January 22, 2014
    Report Date
    January 22, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER PERFORMING A TIGHTNESS TEST, A LEAK WAS DETECTED FROM THE GAS OUTLET PORT. THE OXYGENATOR WAS OPENED TO LOCALIZE THE LEAKAGE SOURCE. USUALLY THE GAS DIFFUSIVE HOLLOW FIBERS ARE CASTED IN POLYURETHANE TO SEPARATE THE GAS COMPARTMENT FROM THE BLOOD COMPARTMENT. UNDER OPTICAL MICROSCOPE THE LEAKAGE WAS CAUSED BY FIBER DETACHMENT FROM THE POLYURETHANE CAUSED BY A DELAMINATION OF 7 GAS FIBERS. THE FLUID FLOWED INSIDE THE GAP BETWEEN THE GAS FIBERS AND POLYURETHANE AND THE GRAVITY GUIDED THE FLUID TO THE GAS EXITING PATH ALONG THE HOUSING. A REVIEW OF OUR MANUFACTURING RECORDS SHOWED THAT THIS OXYGENATOR HAD PASSED THE FINAL 100% TIGHTNESS TEST SUCCESSFULLY. THIS DELAMINATION MIGHT HAVE HAPPENED AFTER STERILIZATION AND DURING AGING PERIOD. THE COMPLAINTS TREND WAS CONSIDERED AND NO MORE COMPLAINTS WERE RECEIVED FROM THIS LOT NUMBER. IN ACCORDANCE WITH THE OPERATING INSTRUCTIONS G-116 IN SECTION 9.2 THE POSSIBILITY OF THIS MALFUNCTION TO TAKE PLACE DURING PRIMING IS DESCRIBED. MAQUET IS AWARE WITH SIMILAR COMPLAINTS REPORTING THE SAME FAILURE. AN INTERNAL PROCESS WAS INITIATED (CAPA (B)(4)) TO DETERMINE THE ROOT-CAUSE AND CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    DURING PRIMING THE USER NOTICED LIQUID LEAKAGE FROM PLS MODULE BEFORE OPERATION. PLS WAS REPLACED WITH A NEW ONE. THE INCIDENT TOOK PLACE IN (B)(6). THE DEVICE IS NOT DISTRIBUTED IN USA BUT SIMILAR DEVICE IS DISTRIBUTED UNDER K112360. REF.#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115069 BE-PLS 2050 PERMANENT LIFE SUPPORT OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG 70102.7818 70090398

    Patients

    Seq Age Sex Outcome Treatment
    1 NA