BEUDAMED
    FDA Adverse Event Death Summary report: N

    BE-HMOD 30000#BE-QUADROX-ID PÄD.O.FILT.

    MDR report key: 9694971 · Received February 11, 2020

    Report

    Report Number
    3008355164-2020-00004
    Event Type
    Death
    Date Received
    February 11, 2020
    Date of Event
    April 29, 2019
    Report Date
    February 11, 2020
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY GMBH REQUESTED THE PRODUCT FOR INVESTIGATION BUT THE PRODUCT WAS NOT AVAILABLE. THEREFORE NO LABORATORY INVESTIGATION COULD BE PERFORMED. A REVIEW FOR SIMILAR COMPLAINTS TO BE INVESTIGATED ALREADY WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND. DURING REVIEW OF THE DEVICE HISTORY RECORDS NO REFERENCES WERE FOUND, WHICH ARE INDICATING A NON-CONFORMANCE. THUS THE REPORTED FAILURE COULD NOT BE CONFIRMED. BASED ON THE INFORMATION AVAILABLE AT THIS TIME THE CAUSE OF THIS FAILURE WAS DETERMINED TO NOT BE ATTRIBUTED TO A DEVICE RELATED MALFUNCTION.

    Description of Event or Problem · 1

    THEY REPORTED A PRE-MEMBRANE PRESSURE OF 380MMHG, IT WAS TRIED TO INCREASE THE FLOW AND IT DID NOT RESPOND, THE BLOOD FLOW TO THE PATIENT DID NOT EXCEED 200ML / MIN. PERFORMED VOLUME TEST BUT THE PATIENT DID NOT RESPOND. IT WAS NOT ELUCIDATED IF THE DEATH IS EXCLUSIVELY RELATED TO DISPOSABLE. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED YET. INTERNAL REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155277 BE-HMOD 30000#BE-QUADROX-ID PÄD.O.FILT. OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH 70124475

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R