BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADROX-ID DIFFUSION MEMBRANE OXYGENATOR

    MDR report key: 4871733 · Received June 25, 2015

    Report

    Report Number
    8010762-2015-00763
    Event Type
    Injury
    Date Received
    June 25, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CLOTTING IS A KNOWN PHENOMENON TO MAQUET CARDIOPULMONARY (B)(4) AND HAS BEEN THOROUGHLY INVESTIGATED IN A PREVIOUS COMPLAINT. BASED ON THE RESULTS OBTAINED DURING THE PREVIOUS INVESTIGATION AND THE INFO AVAILABLE TO US AT THIS TIME, THE DEVICE OPERATED WITHIN MAQUET SPECS, THEREFORE, NON-DEVICE RELATED FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE FAILURE WILL BE HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRACK AND TRENDING PROCESS. IF A TREND OCCURS, FURTHER ACTIONS WILL BE TAKEN REFERENCE EXEMPTION# (B)(4).

    Additional Manufacturer Narrative · 1

    UF/IMPORTER REPORT # WAS REPORTED AS 3008355164-2015-000135 WHEREAS IT SHOULD HAVE BEEN REPORTED AS 3008355164-2015-00135.

    Description of Event or Problem · 1

    REFERENCE IMPORTER REPORT NUMBER: (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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411843 QUADROX-ID DIFFUSION MEMBRANE OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1