BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BE-PLS 2050 # PERMANENT LIFE SUPPORT SET

    MDR report key: 4615650 · Received March 12, 2015

    Report

    Report Number
    8010762-2015-00257
    Event Type
    Malfunction
    Date Received
    March 12, 2015
    Date of Event
    February 12, 2015
    Report Date
    February 12, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTR
    PMA / PMN Number
    K101153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR HAS REQUESTED DETAILED INFO BUT COULD NOT YET OBTAIN ANY INFO ABOUT THE ACTUAL PRODUCT IN QUESTION, THE LOCATION OF THE LEAKAGE OR THE EFFECTS ON THE PT. THE MFR ALSO REQUESTED THE PRODUCT FOR EVAL. THE PRODUCT MENTIONED 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. A SUPPLEMENTAL REPORT WILL BE SENT WHEN ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXHIBITED FAILURE AS "DISRUPTION OF MEMBRANE" CAUSING MAJOR LEAKAGE ON THE MEMBRANE. THIS TOOK PLACE DURING ARTIFICIAL CARDIOPULMONARY PROLONGED ASSISTANCE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171414 BE-PLS 2050 # PERMANENT LIFE SUPPORT SET TUBING SET, HEART - LUNG BYPASS DTR MAQUET CARDIOPULMONARY AG 70102.7818

    Patients

    Seq Age Sex Outcome Treatment
    1