BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BE-PLS 20151 # PERMANENT LIFE SUPP SET PLU

    MDR report key: 4340116 · Received December 9, 2014

    Report

    Report Number
    8010762-2014-01335
    Event Type
    Malfunction
    Date Received
    December 9, 2014
    Date of Event
    November 12, 2014
    Report Date
    November 12, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTR
    PMA / PMN Number
    K101153
    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. THE DEVICE DISPLAYED A SIMILAR MALFUNCTION WHICH WHERE TESTED AND EVALUATED UNDER AN OPTICAL MICROSCOPE. DELAMINATION OF SAME 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% 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. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN NEW INFO BECOMES AVAILABLE. ADDITIONAL INFO: THE PRODUCT MENTIONED UNDER SECTION D IS NOT DISTRIBUTED TO THE UNITED STATES, BUT HE PRODUCT WITH CONTRIBUTING DESIGN FUNCTION TO THE AFFECTED COMPONENT (QUADROX-ID) IS REGISTERED UNDER 510(K): K101153.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE ON A PT, BLOOD LEAKAGE WAS NOTED AT THE GAS OUTLET OF THE DEVICE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796894 BE-PLS 20151 # PERMANENT LIFE SUPP SET PLU TUBING SET DTR MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1