BEUDAMED
    FDA Adverse Event Death Summary report: N

    HLM TUBING SET W/BIOLINE COATING

    MDR report key: 5932887 · Received September 7, 2016

    Report

    Report Number
    8010762-2016-00553
    Event Type
    Death
    Date Received
    September 7, 2016
    Date of Event
    August 26, 2016
    Report Date
    August 26, 2016
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K080592
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION; THEREFORE NO MANUFACTURER LABORATORY INVESTIGATION WAS POSSIBLE. TREND SEARCH: A SAP TREND SEARCH WAS PERFORMED FOR P/N 70102.7818 FAILURE CODE 0306 OXYGENATION AND TWO ADDITIONAL COMPLAINTS WERE FOUND. BOTH OF THEM ARE CLOSED ALREADY. NO DEVICE RELATING FACTORS WERE DETERMINED CAUSING THE REPORTED FAILURE. DUE TO THIS INFORMATION NO SYSTEMIC ISSUE COULD BE DETERMINED. CLINICAL ASSESSMENT: DUE TO THE FACT THAT THE PATIENT WAS DROWNED IT IS STRONGLY ASSUMED THAT THE MOST PROBABLE CAUSE OF THE EVENT WAS NOT RELATED TO A DEVICE RELATED MALFUNCTION. MOST PROBABLE WATER WAS ACCUMULATING WITHIN THE BODY OF THE PATIENT WHICH DID DIFFUSE ONTO THE BLOOD SIDE OF THE OXYGENATOR AND BY THIS WAY WAS ENTERING THE ECMO SYSTEM - CONSEQUENTLY THE OXYGENATOR. THERE, THE ACCUMULATED WATER PROBABLE CAUSED AN INCREASING REDUCTION OF THE GAS EXCHANGE PERFORMANCE, WHICH SUBSEQUENTLY CAUSED THE REPORTED PHENOMENON. BASED ON THIS A CONFIRMATION OF A DEVICE RELATED MALFUNCTION IS NOT POSSIBLE. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME.

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER: AFTER ECMO HAD RUN FOR 30 MINUTES, OXYGEN SATURATION WAS DROPPED SUDDENLY TO 20% AND THE PO2 WAS 90. THE DOCTOR FOUND THE BLOOD AND TRANSPARENT LIQUID(MAYBE WATER) LAYERED AS THE PICTURE SHOWED, AND IT WAS OK OF THE INLET SIDE. SO THEY EXCHANGED OTHER SET. DURING THE EXCHANGE, OXYGEN SATURATION WAS LOW AND THE HEART RATE DROPPED. THREE HOURS AFTER THEY FINISHED THE EXCHANGE, THE PATIENT DIED BECAUSE SHE COULD NOT MAINTAIN HER HEART RATE. (B)(4).

    Description of Event or Problem · 1

    (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583855 HLM TUBING SET W/BIOLINE COATING TUBING, PUMP, CARDIOPULMONARY BYPASS DWE MAQUET CARDIOPULMONARY AG BE-PLS 2050 70109934

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death