BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX-ID PEDIATRIC

    MDR report key: 2941420 · Received January 31, 2013

    Report

    Report Number
    8010762-2013-00004
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K100278
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MFR 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. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. THE CLOTTING WAS REPORTED TO HAVE OCCURRED WELL BEYOND THE 6 HOURS OF USE, AS NOTED IN THE INDICATIONS FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A QUADROX PEDIATRIC OXYGENATOR CLOTTED OFF AFTER 12 HOURS OF USE AND ANOTHER AFTER 16 HOURS. THE PATIENT WAS THEN SWITCHED TO AN ADULT QUADROX OXYGENATOR. NO PATIENT EFFECTS WERE REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42991 QUADROX-ID PEDIATRIC OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG BEQ-HMOD30000-USA 70080078

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention