BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET W/BIOLINE COATING

    MDR report key: 4737020 · Received April 27, 2015

    Report

    Report Number
    8010762-2015-00404
    Event Type
    Malfunction
    Date Received
    April 27, 2015
    Date of Event
    April 8, 2015
    Report Date
    April 8, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S INVESTIGATION OF THE PRODUCT IS STILL PENDING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFO BECOMES AVAILABLE. ADDITIONAL INFO: THE PRODUCT MENTIONED UNDER SECTION D IS A SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-ID WHICH IS REGISTERED UNDER 510 (K): K101153.

    Description of Event or Problem · 1

    ACCORDING TO CUSTOMER'S INFO: DURING THE SET PRIMING AND FOLLOWING THE PRIMING PROCEDURE, WHEN THE SPEED WAS INCREASED TO 4000 RPM, A STRANGE NOISE WAS HEARD IN THE CARDIOHELP DRIVER AND MASSIVE AIR ENTERED IN THE SET AND MEMBRANE THAT COULD NOT BE REMOVED. THE SET WAS REPLACED WITH A NEW ONE THAT WAS PRIMED WITHOUT ANY PROBLEM AND THE PT WAS PUT IN ECMO SUCCESSFULLY. NO FURTHER PROBLEM WAS EXPERIENCED WITH THE NEW SET OR THE CARDIOHELP DEVICE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276098 HLM TUBING SET W/BIOLINE COATING DTZ MAQUET CARDIOPULMONARY AG BE-HLS 7050 70099505

    Patients

    Seq Age Sex Outcome Treatment
    1