BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    01970110#QUADROX-I WITHOUT ARTERIAL FILTER

    MDR report key: 3800587 · Received February 11, 2014

    Report

    Report Number
    8010762-2014-00038
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 19, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS NOT CLEAR AS TO WHETHER THE DEVICE IS OBTAINABLE FOR INVESTIGATION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LEAKAGE OF PRIMING SOLUTION FROM THE BLOOD INLET LUER LOCK. REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90033 01970110#QUADROX-I WITHOUT ARTERIAL FILTER QUADROX-I WITHOUT ARTERIAL FILTER DTZ MAQUET CARDIOPULMONARY AG 01970110 70083925

    Patients

    Seq Age Sex Outcome Treatment
    1 NA