BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HMOD70000#QUADROX-ID

    MDR report key: 3674059 · Received February 6, 2014

    Report

    Report Number
    8010762-2014-00035
    Event Type
    Injury
    Date Received
    February 6, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED LACK OF EFFICIENCY WAS CAUSED BY EXCEEDING SERVICE/SHELF LIFE OF THE QUADROX-ID OXYGENATOR. IT HAD BEEN USED FOR 2 DAYS; HOWEVER, IT IS CLEARLY STATED IN IFU G-152 2013-09, PAGE 4 " THE APPLICATION DURATION IS LIMITED FOR 6 HOURS". (B)(4).

    Description of Event or Problem · 1

    REFERENCE IMP# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77565 HMOD70000#QUADROX-ID DIFFUSION MEMBRANE OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1