BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET W/BIOLINE COATING

    MDR report key: 4711968 · Received April 17, 2015

    Report

    Report Number
    8010762-2015-00380
    Event Type
    Malfunction
    Date Received
    April 17, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 1, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K101153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN INVESTIGATED IN THE LABORATORY OF THE MANUFACTURER WITH THE FOLLOWING RESULTS: DURING TESTING THE PRODUCT FOR TIGHTNESS A FLUID LEAKAGE AT THE TUBE CONNECTION OF THE BLOOD INLET CONNECTOR WAS DETECTED. THE EVENT REPORT OF COMPLAINT # (B)(4) WAS NOT DESCRIBING THIS ISSUE. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET TRENDING PROCESS. IF A TREND OCCURS, IT WILL BE ESCALATED TO QUALITY ASSURANCE MANAGEMENT FOR REVIEW AND DETERMINATION OF APPLICABLE INVESTIGATION. DUE TO THIS NO FURTHER ACTION WILL BE COMPLETED AT THIS TIME. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED IS A TUBING 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

    INVESTIGATION RESULTS OUT OF COMPLAINT (B)(4) (8010762-2015-00267) THE PRODUCT HAS BEEN INVESTIGATED IN THE LABORATORY OF THE MANUFACTURER WITH THE FOLLOWING RESULTS: DURING TESTING THE PRODUCT FOR TIGHTNESS A FLUID LEAKAGE AT THE TUBE CONNECTION OF THE BLOOD INLET CONNECTOR OF THE OXYGENATOR WAS DETECTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256162 HLM TUBING SET W/BIOLINE COATING DWE DWE MAQUET CARDIOPULMONARY AG BE-HLS 7050

    Patients

    Seq Age Sex Outcome Treatment
    1