BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HLM TUBING SET

    MDR report key: 5752023 · Received June 27, 2016

    Report

    Report Number
    8010762-2016-00411
    Event Type
    Injury
    Date Received
    June 27, 2016
    Date of Event
    June 8, 2016
    Report Date
    June 8, 2016
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY REQUESTED THE PRODUCT BACK FOR INVESTIGATION BUT PRODUCT WAS NOT AVAILABLE. FURTHERMORE PRODUCT DATA REGARDING THE INVOLVED SET HAS BEEN REQUESTED BUT NONE COULD BE PROVIDED BY CUSTOMER. ONLY THE DATA OF THE INVOLVED OXYGENATOR HAS BEEN SUBMITTED TO MANUFACTURER. A REVIEW FOR SIMILAR COMPLAINTS FOR THE SPECIFIC PRODUCT HAS BEEN PERFORMED AND NO SIMILAR INCIDENT WITH A FAILURE CONFIRMED WAS FOUND. BASED ON THIS A CONFIRMATION OF THE FAILURE IS NOT POSSIBLE. SINCE THE REPORTED FAILURE DID NOT CONTRIBUTE TO A DEATH OR SERIOUS INJURY NO CORRECTIVE ACTION IS NEEDED. IN ADDITION AT THIS TIME IT CANNOT BE CONCLUDED THAT THIS IS AN SYSTEMATIC ERROR. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION 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 INVESTIGATION INITIATIONS 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-I WHICH IS REGISTERED UNDER 510(K): K082117.

    Description of Event or Problem · 1

    DESCRIPTION FROM THE CUSTOMER REPORT: "AS SOON AS WE WENT ON CARDIOPULMONARY BYPASS THE ABG SHOWED LOW PO2 40MMHG EVEN WITH 100% FI02 AND BLOOD FLOW OF 4.0L/MIN. NEED TO CHANGE OXYGENATOR AND RESUME BYPASS" (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404608 HLM TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention