BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BE-PLS 2050 PERMANENT LIFE SUPPORT

    MDR report key: 3823777 · Received February 20, 2014

    Report

    Report Number
    8010762-2014-00067
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 18, 2014
    Report Date
    January 22, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND CORRECTIVE ACTIONS FOR THE DEVICE DESCRIBED IN THIS REPORT. THE INCIDENT TOOK PLACE IN POLAND. THE DEVICE IS NOT DISTRIBUTED IN USA BUT SIMILAR DEVICE IS DISTRIBUTED UNDER K112360. THE MANUFACTURER HAS NOT RECEIVED THE DEVICE FOR INVESTIGATION. A REQUEST TO OBTAIN THE DEVICE WAS ISSUED. ONCE THE DEVICE BECAME AVAILABLE, THE INVESTIGATION WILL BEGIN TO DETERMINE THE ROOT-CAUSE. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AS SOON AS FURTHER INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BE-PLS 2050 WAS CONNECTED TO THE PT AFTER CARDIAC TRANSPLANTATION, AND CARDIOTOMY FAILURE. AFTER CONNECTING SET AND START ECMO PROCEDURE, THE PERFUSIONIST NOTICED THE BLOOD LEAKAGE ON THE LOWER PART OF THE OXYGENATOR. AFTER A SHORT TIME, THE LEAKAGE OF THE BLOOD INTENSIFIED AND THEY DECIDED TO EXCHANGE THE WHOLE SET BE-PLS 2050 FOR A NEW ONE. REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106578 BE-PLS 2050 PERMANENT LIFE SUPPORT DIFFUSION MEMBRANE OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG 70102.7818 70090402

    Patients

    Seq Age Sex Outcome Treatment
    1 NI