BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX D

    MDR report key: 2202305 · Received August 5, 2011

    Report

    Report Number
    8010762-2011-00007
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Report Date
    July 25, 2011
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT#: 70048083. MAQUET CARDIOVASCULAR SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MFR OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). ADD'L INFO IS BEING REQUESTED. AWAITING PRODUCT RETURN FOR EVAL. (B)(4).

    Description of Event or Problem · 1

    TWO OXYGENATORS DEVELOPED A CRACK ON THE HOUSING DURING USE. THE OXYGENATORS WERE USED PARALLEL. A ROLLER PUMP WAS USED. LOT# 70040993 (IN USE 52 HRS), LOT# 70048083 (IN USE 24 HRS). THERE WAS NO ADVERSE EFFECT TO THE PT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADROX D NONE DTZ MAQUET CARDIOPULMONARY AG HMOD 2030 70040993

    Patients

    Seq Age Sex Outcome Treatment
    1 NI