BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGENATOR WITH INTEGRATED HEAT EXCHANGER

    MDR report key: 8347727 · Received February 18, 2019

    Report

    Report Number
    8010762-2019-00037
    Event Type
    Malfunction
    Date Received
    February 18, 2019
    Date of Event
    February 5, 2019
    Report Date
    February 18, 2019
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K100278
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). MAQUET (B)(4) REQUESTED THE PRODUCT FOR INVESTIGATION IN THE LABORATORY OF THE MANUFACTURER. AS STATED ON 2019-02-14 BY THE CUSTOMER "ALL THE OXYGENATORS WERE THROUGHOUT" THEREFORE NO LABORATORY INVESTIGATION COULD BE PERFORMED BY THE MANUFACTURER. A REVIEW FOR SIMILAR COMPLAINTS TO BE INVESTIGATED ALREADY WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND. THUS THE REPORTED FAILURE COULD NOT BE CONFIRMED. ACCORDING TO THE STATEMENT OF THE CUSTOMER FROM 2019-02-10 "WE KNOW IT¿S THE PATIENT. WE KNOW IT¿S NOT THE OXYS" AND FROM 2019-02-14 "I THREW IT OUT AS IT WAS USER ERROR". BASED ON THE INFORMATION AVAILABLE AT THIS TIME THE CAUSE OF THIS FAILURE WAS DETERMINED TO NOT BE ATTRIBUTED TO A DEVICE RELATED MALFUNCTION. SINCE THE REPORTED FAILURE DID NOT CONTRIBUTE TO A DEATH OR SERIOUS INJURY AND NO SYSTEMIC ISSUE COULD BE DETERMINED NO CORRECTIVE ACTION IS NEEDED AT THIS TIME. 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. REFERENCE EXEMPTION # E2018002.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER: ON (B)(6) 2019 ~20:00, TRANSMEMBRANE PRESSURES (DIFFERENCE BETWEEN GOING INTO THE OXYGENATOR AND COMING OUT) WERE NOTED TO BE INCREASING ABOVE 40MMHG (AVERAGE IS ~10 MMHG). THE TRANSMEMBRANE PRESSURES WERE TOLERATED FOR A COUPLE MORE HOURS UNTIL A REDUCTION OF FLOW WAS NOTED DUE TO THE INCREASE IN RESISTANCE GOING INTO THE OXYGENATOR. AT (B)(6) 2019 ~0:00, THE TRANSMEMBRANE PRESSURES WERE 60 MMHG AND THE TEAM ELECTED TO CHANGE THE OXYGENATOR OUT. NO HARM TO THE PATIENT WAS REPORTED. ACCORDING TO THE INITIAL COMPLAINT REPORT ANOTHER OXY WAS ALSO INVOLVED IN THE INCIDENT. FOR THE SECOND OXYGENATOR A SEPARATE COMPLAINT HAS BEEN OPENED IN SAP - (B)(4). NEW INFO RECEIVED ON 2019-02-10 THAT A THIRD OXY IS ALSO INVOLVED. FOR THIS FOLLOW INCIDENT A FURTHER COMPLAINT IN SAP HAS BEEN OPENED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141967 OXYGENATOR WITH INTEGRATED HEAT EXCHANGER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG BEQ-HMOD30000-USA#Q 70124528

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention