BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX-ID

    MDR report key: 2854520 · Received November 29, 2012

    Report

    Report Number
    8010762-2012-00052
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENOUS INLET HAD DISCONNECTED FROM THE BASE OF THE OXYGENATOR WHILE FLOWING AT 4LPM. THE INLET WAS HELD IN PLACE WHILE ANOTHER CIRCUIT WAS PREPARED. THE PATIENT WAS STABLE DURING THE ENTIRE PROCESS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADROX-ID OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG HMOD-70000-USA 70075647

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other