BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEQ-HMOD70000-USA#QUADROX-ID AD.O.FIL.

    MDR report key: 3834569 · Received May 2, 2014

    Report

    Report Number
    8010762-2014-00200
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    March 28, 2014
    Report Date
    October 20, 2017
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K132829
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 CORRECTIVE ACTIONS FOR THE DEVICE DESCRIBED IN THIS REPORT. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS INVESTIGATED AT THE LABORATORY OF THE MANUFACTURER. A TIGHTNESS TEST OF THE OXYGENATORS BLOOD SIDE WAS PERFORMED. HEREBY A LEAKAGE FROM THE GAS EXHAUST PORT WAS NOT CONFIRMED. THUS THE REPORTED FAILURE "LEAKAGE FROM GAS EXHAUST PORT" COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OXYGENATOR LEAKED AT THE EXHAUST PORT AND THE PT LOST A FAIR AMOUNT OF BLOOD. IN THE OPERATING ROOM INITIATION OF ECMO AND PRIOR TO LEAVING THE OPERATING ROOM THE PT RECEIVED 6 PACKED CELLS, 6 UNITS FROZEN PLASMA, 10 UNITS OF CTYOPRECIPITATE AND ONE UNIT OF PLATELETS. THE DEVICE WAS CHANGED OUT. THE PT HAS SINCE RECOVERED. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265282 BEQ-HMOD70000-USA#QUADROX-ID AD.O.FIL. OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG 70093821

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention