BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HMO 71000-J#QUADROX-1 ADULT + FILTER

    MDR report key: 4580239 · Received March 3, 2015

    Report

    Report Number
    8010762-2015-00100
    Event Type
    Malfunction
    Date Received
    March 3, 2015
    Date of Event
    February 2, 2015
    Report Date
    February 4, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY IS AWARE OF SIMILAR COMPLAINTS FOR THIS PRODUCT. AN INTERNAL PROCESS TO INVESTIGATE THE ROOT-CAUSE FOR THIS FAILURE HAS BEEN INITIATED (CAPA (B)(4)). MFR'S REVIEW OF THE PRODUCTION PROCESS HAS SHOWN THAT A 100% FINAL INSPECTION FOR LEAKAGE IS PERFORMED BEFORE THE PRODUCTS ARE RELEASED FOR DISTRIBUTION. ADDITIONAL INFO: THE PRODUCT MENTIONED UNDER SECTION D IS NOT DISTRIBUTED TO THE US, BUT THE PRODUCT WITH CONTRIBUTING DESIGN FUNCTION TO THE AFFECTED COMPONENT (QUADROX-I) IS REGISTERED UNDER 510 (K): K082117.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD LEAKAGE ON THE DIALYSIS LOCK AND VALVE WERE DETECTED JUST AFTER INITIATING CARDIAC ASSISTANCE. BLOOD LOSS FOR 5 TO 10 MINUTES WAS OBSERVED BUT THE TOTAL AMOUNT OF BLOOD LOST IS UNK. THE DECISION WAS MADE TO CONTINUE USING THE DEVICE JUDGING FROM THE AMOUNT LOST BLOOD. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE PRODUCT. NO REPORTED PT EFFECT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145725 HMO 71000-J#QUADROX-1 ADULT + FILTER MICROPOROUS MEMBRANE OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG 70104.8762 70098506

    Patients

    Seq Age Sex Outcome Treatment
    1