BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX-ID PEDIATRIC

    MDR report key: 2945425 · Received February 1, 2013

    Report

    Report Number
    8010762-2013-00005
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Report Date
    January 7, 2013
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K100278
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. THERE IS NO INFORMATION AVAILABLE ON HOW LONG THE OXYGENATOR WAS IN USE BEFORE CLOTTING WAS OBSERVED. A LOT NUMBER HAS NOT BEEN REPORTED AND THE DEVICE IS NOT AVAILABLE FOR EVALUATION AND THUS COULD NOT BE EVALUATED . THEREFORE, IT IS NOT POSSIBLE TO CONFIRM THE REPORTED COMPLAINT. THE PATIENT HISTORY AND MEDICAL TREATMENT HAVE NOT BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER CHANGED OUT ONE PEDIATRIC QUADROX-ID OXYGENATOR DUE TO CLOTTING AND HIGH DELTA PRESSURES. ALL COAGULATION PARAMETERS WERE REPORTED WITHIN NORMAL PRACTICE, ACT, PTT, AND PLATELET COUNT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43768 QUADROX-ID PEDIATRIC OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG BEQ-HMOD30000-USA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention