BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR

    MDR report key: 4871763 · Received June 25, 2015

    Report

    Report Number
    3008355164-2015-00135
    Event Type
    Injury
    Date Received
    June 25, 2015
    Date of Event
    May 21, 2015
    Report Date
    May 21, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE CLOTTED, REQUIRING REPLACEMENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED JULY 1, 2015: CLOTTING WAS THROUGH THE ENTIRE DEVICE. TREATMENT WAS DELAYED 30 SECONDS FOR THE EXCHANGE, WITH NO REPORTED PATIENT EFFECT. CLOTTING WAS NOTED AFTER SLOW FLOW WAS DETECTED. DURING THE CASE NON MAQUET PRODUCTS WERE USED. MEDTRONIC CANNULAS AND CENTRI MAGS BLOOD PUMP. ANTICOAGULATION WAS CONDUCTED PER HOSPITAL PROTOCOL WITH ACT'S TAKEN PER HOSPITAL PROTOCOL. UF/IMPORTER REPORT # WAS REPORTED AS 3008355164-2015-000135 WHEREAS IT SHOULD HAVE BEEN REPORTED AS 3008355164-2015-00135.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411824 QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG HMOD 70000-USA 70103789

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention