BEUDAMED
    FDA Adverse Event Death Summary report: N

    OXYGENATOR WITH INTEGRATED HEAT EXCHANGER

    MDR report key: 8504524 · Received April 11, 2019

    Report

    Report Number
    8010762-2019-00098
    Event Type
    Death
    Date Received
    April 11, 2019
    Date of Event
    March 29, 2019
    Report Date
    June 5, 2019
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MAQUET MEDICAL SYSTEMS,USA(IMPORTER)SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31, 76437 RASTATT, GERMANY. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. IMPORTER- MAQUET MEDICAL SYSTEMS USA 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON- (B)(4). THE RETURNED OXYGENATOR BEQ-HMOD 70000 WITHOUT FILTER WAS INVESTIGATED IN THE LABORATORY OF THE MANUFACTURER. A VISUAL INVESTIGATION OF THE AFFECTED OXY GENATOR AS PERFORMED DURING THE INSPECTION A CRACK ON THE ROTATED ADAPTER (NO NEGATIVEE AFFECT ON THE DEVICE) AND THE TUBES ARE NOT SECURED WITH TIES (THAT IS IN THE RESPONSIBILITY OF THE USER). THE OXY WAS CLEANED WITH NATRIUMHYPOCHLORID NO CLOTS WERE DETECTED. A TIGHTNESS TEST ACCORDING TO LV 201 WAS PERFORMED. A WATER CYCLE WITH A ROLLER PUMP WAS SET UP. RECONSTUCTING OF THE PROCESS AS BY THE CUSTOMER IS NOT POSSIBLE IN THE LABORATORY, DUE TO UNEQUAL CIRCUMSTANCES. THUS THE REPORTED FAILURE COULD NOT BE CONFIRMED. ACCORDING TO THE STATEMENT OF THE CUSTOMER "THE CHANGE OUT OF THE OXYGENATOR DID NOT CONTRIBUTE TO HER PASSING" ACCORDING TO THE CLINICAL EVALUATION BY OUR CLINICAL DIRECTOR: THE DEVICE WAS INVESTIGATED IN TERMS OF THE FUNCTION WITHOUT A CAUSAL EXPLANATION OF THE PROCESS COULD TAKE PLACE. THE STATEMENT IN THE COMPLAINT ALSO SEES NO CONNECTION TO THE DEATH; MOST LIKELY IT CAME TO A CLOTTING OF THE OXYGENATOR, WHICH HAS MADE AN EXCHANGE NECESSARY; WE KNOW NOTHING ABOUT THE COAGULATION STATUS OF THE PATIENT, SO WE CAN ONLY SPECULATE WHETHER THE BLOOD WAS SUFFICIENTLY HEPARINIZED OR NOT. IT COULD BE CONCLUDED THAT NO PRODUCT FAILURE WAS THE CAUSE." SINCE NO DEVICE RELATED MALFUNCTION COULD BE CONFIRMED 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.

    Additional Manufacturer Narrative · 0

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). DEVICE REQUESTED BUT NOT YET RECEIVED. REFERENCE EXEMPTION # E2018002.

    Description of Event or Problem · 0

    INTERNAL REFERENCE: (B)(4).

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER: THEY PLACED A (B)(6) FEMALE ON SUPPORT WITH THE QUADROX AND 20 MINUTES INTO THE RUN THE FLOW STOPPED. HE SAID HIGH RPMS AND HIGH PRE OXY PRESSURE THEN LOW POST OXY PRESSURE. THEY EVEN PUT ANOTHER FLOW PROBE ON AND IT HAD ZERO FLOW. THEY CHANGED OUT THE QUADROX AND FLOWS AND VITALS AND PRESSURE AS WELL VITALS NORMALIZED. PT WAS A SALVAGE DISSECTION FROM THE ER AND WAS PRONOUNCED 2 AND HALF HOURS LATER IN THE UNIT AFTER BEING PLACED ON SUPPORT. (B)(6) STATED THE CHANGE OUT OF THE OXYGENATOR DID NOT CONTRIBUTE TO HER PASSING". INTERNAL REFERENCE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299414 OXYGENATOR WITH INTEGRATED HEAT EXCHANGER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH BEQ-HMOD70000-USA # 70123611

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death