BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HLM TUBING SET W/BIOLINE COATING

    MDR report key: 4914768 · Received July 13, 2015

    Report

    Report Number
    8010762-2015-00799
    Event Type
    Injury
    Date Received
    July 13, 2015
    Date of Event
    June 26, 2015
    Report Date
    June 26, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT AVAILABLE FOR MANUFACTURER'S LABORATORY INVESTIGATION. A REVIEW FOR SIMILAR COMPLAINTS HAS BEEN PERFORMED AND NO SIMILAR INCIDENT WAS FOUND. BASED ON THIS A CONFIRMATION OF THE FAILURE IS NOT POSSIBLE. THIS DATA WILL BE HANDLED THROUGH A DESIGNATED MAQUET TRENDING PROCESS. IF A TREND OCCURS, IT WILL BE ESCALATED TO QUALITY ASSURANCE MANAGEMENT FOR REVIEW AND DETERMINATION IF FURTHER INVESTIGATION IS NECESSARY. DUE TO THIS NO FURTHER ACTION WILL BE COMPLETED AT THIS TIME. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED UNDER SECTION D 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

    ACCORDING TO THE CUSTOMER: "WHEN SETTING UP THE CIRCUIT, CUSTOMER COULDN'T GET THE ARTERIAL PRESSURE READING. THEY USED A SECOND MACHINE WITH SAME RESULTS. THEY ELECTED TO KEEP THE CIRCUIT DUE TO THE EMERGENCY OF THE SITUATION. PATIENT IS STILL ON THE CIRCUIT BUT THEY DON'T HAVE AN ARTERIAL READING AND DELTA P. THE CUSTOMER DISPOSED OF THE PRODUCT. " (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452431 HLM TUBING SET W/BIOLINE COATING DWE DWE MAQUET CARDIOPULMONARY AG BE-HLS 7050 70104099

    Patients

    Seq Age Sex Outcome Treatment
    1 Other