BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX-ID

    MDR report key: 3674865 · Received February 20, 2014

    Report

    Report Number
    3008355164-2014-00034
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 22, 2014
    Report Date
    January 27, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OXYGENATOR WAS CHANGED OUT WHILE DELIVERING ECLS TO A NEONATAL PATIENT. NO PATIENT HARM INDICATED. (B)(4). REF MFR # 8010762-2014-00092.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106744 QUADROX-ID DIFFUSIVE MEMBRANE OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI