BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR VHK

    MDR report key: 4951757 · Received July 28, 2015

    Report

    Report Number
    8010762-2015-00841
    Event Type
    Malfunction
    Date Received
    July 28, 2015
    Date of Event
    July 24, 2015
    Report Date
    July 24, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTN
    PMA / PMN Number
    K102919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING INVESTIGATION OF A COMPLAINT, AN ADDITIONAL MALFUNCTION WAS FOUND. THIS ADDITIONAL COMPLAINT WAS OPENED IN ORDER TO COVER THE FAILURE. MAQUET CARDIOPULMONARY (B)(4) IS AWARE OF SIMILAR COMPLAINTS SHOWING A SIMILAR MALFUNCTION. MOST PROBABLE ROOT CAUSE IS THAT THE BLUE PIECES COME FROM THE CONNECTED RESERVOIR (WELDING POINTS). DUE TO THIS NO FURTHER ACTION WILL BE COMPLETED AT THIS TIME. THIS DATA IS BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRACKING AND TRENDING PROCESS. ABBREVIATION NC: NONCONFORMANCE. ADDITIONAL INFO: THE PRODUCT MENTIONED IS A TUBING SET WITH RESERVOIR AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE RESERVOIR WHICH IS REGISTERED UNDER 510 (K): K102919.

    Description of Event or Problem · 1

    THE PRODUCT WAS INVESTIGATED UNDER COMPLAINT# (B)(4) AND AN ADDITIONAL FAILURE WAS FOUND AS FOLLOWS: "BLUE PIECE OF PLASTIC WERE DETECTED IN THE OXYGENATOR". THIS ADDITIONAL COMPLAINT WAS OPENED IN ORDER TO COVER THIS FAILURE. REF.#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488514 RESERVOIR VHK DTN MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1