BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VKMO 11000 #QUADROX-I NEO. MIT RESERVOIR

    MDR report key: 4643329 · Received March 27, 2015

    Report

    Report Number
    8010762-2015-00309
    Event Type
    Injury
    Date Received
    March 27, 2015
    Date of Event
    March 4, 2015
    Report Date
    March 5, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K102464
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY HAS RECEIVED THE PRODUCT IN QUESTION FOR EVAL. THE INVESTIGATION RESULTS ARE PENDING. A SUPPLEMENTAL REPORT WILL BE PROVIDED WHEN NEW INFO BECOMES AVAILABLE. ADD'L INFO: THE PRODUCT MENTIONED, IS NOT DISTRIBUTED TO THE UNITED STATES, BUT THE PRODUCT WITH CONTRIBUTING DESIGN FUNCTION TO THE AFFECTED COMPONENT (QUADROX-I, NEONATAL) IS REGISTERED UNDER 510 (K): K102464.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLOOD CLOTTED DURING PRIMING. THE PRODUCT WAS REPLACED. THEREFORE, THE PROCEDURE WAS DELAYED FOR ABOUT 30 MINS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204795 VKMO 11000 #QUADROX-I NEO. MIT RESERVOIR DTZ WITH DTN DTZ MAQUET CARDIOPULMONARY AG 70104.9279 92137824

    Patients

    Seq Age Sex Outcome Treatment
    1 Other