BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BE-PLS 2051 #PERMANENT LIFE SUPP. SET PLU

    MDR report key: 4346528 · Received December 16, 2014

    Report

    Report Number
    8010762-2014-01344
    Event Type
    Injury
    Date Received
    December 16, 2014
    Report Date
    November 24, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY IS AWARE OF SIMILAR COMPLAINTS. THE DEVICES DISPLAYED A SIMILAR MALFUNCTION WHICH WERE TESTED AND EVALUATED UNDER AN OPTICAL MICROSCOPE. DELAMINATION OF SOME GAS FIBERS WAS OBSERVED WHICH ALLOWED FOR THE PRIMING SOLUTION OR BLOOD TO FLOW INSIDE THE GAP BETWEEN THE GAS FIBERS AND POLYURETHANE. GRAVITY THEN ALLOWED FOR PASSAGE TO THE GAS EXITING PATH ALONG THE HOUSING. THE MOST PROBABLE ROOT-CAUSE IS THE DELAMINATION OF THE HOLLOW GAS FIBERS FROM THE POLYURETHANE POTTING AREA. A REVIEW OF THE QUALITY CONTROL PROCESS CONFIRMS THAT 100 PERCENT FUNCTIONAL INSPECTION FOR LEAKAGE IS PERFORMED DURING PRODUCTION. MAQUET CARDIOPULMONARY AG HAS INITIATED AN INTERNAL PROCESS (CAPA (B)(4)) TO ADDRESS THE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTION. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED UNDER SECTION D IS NOT DISTRIBUTED TO THE U.S., BUT THE PRODUCT WITH THE CONTRIBUTING DESIGN FUNCTION TO THE AFFECTED COMPONENT (QUADROX-ID) IS REGISTERED UNDER 510 (K): K101153. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWENTY MINUTES AFTER INITIATING THERAPY, BLOOD LEAKAGE AT THE GAS OUTLET OF THE DEVICE WAS OBSERVED. THE DEVICE WAS REPLACED. NO CLINICAL CONSEQUENCES WERE REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822038 BE-PLS 2051 #PERMANENT LIFE SUPP. SET PLU TUBING SET DTZ MAQUET CARDIOPULMONARY AG 70099586

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention