BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HLM TUBING SET W/BIOLINE COATING

    MDR report key: 4867693 · Received June 23, 2015

    Report

    Report Number
    8010762-2015-00749
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    June 4, 2015
    Report Date
    June 10, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT REQUESTED TO RETURN FOR MANUFACTURERS INVESTIGATION AS THE FAILURE IS KNOWN AND HAS BEEN INVESTIGATED IN A PREVIOUS COMPLAINT. THE CAUSE OF THIS FAILURE WAS DETERMINED TO NOT BE ATTRIBUTED TO A DEVICE RELATED MALFUNCTION. BASED ON THE PREVIOUS INVESTIGATION RESULTS AND THE INFO AVAILABLE AT THIS TIME, THE OXYGENATOR IN QUESTION OPERATED WITHIN MAQUET CARDIOPULMONARY SPECIFICATIONS. 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 INFO: 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

    ACCORDING TO THE CUSTOMER: "IT WAS MENTIONED TO ME WHILE SUPPORTING A PT ON THE HLS SYSTEM THE DELTA PRESSURES WERE HIGHER THAN USUAL AT THE INITIATION OF SIFROM INITIATION OF SUPPORT." REF.: #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405384 HLM TUBING SET W/BIOLINE COATING DWE (OR DTZ) DWE MAQUET CARDIOPULMONARY AG BEQ-HLS 7050 USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention