BEUDAMED
    FDA Adverse Event Death Summary report: N

    REF.: # 703005384 CUSTOMER REF.: 15-0536

    MDR report key: 5091486 · Received September 21, 2015

    Report

    Report Number
    8010762-2015-01054
    Event Type
    Death
    Date Received
    September 21, 2015
    Date of Event
    August 17, 2015
    Report Date
    August 26, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2015 12:04 PM (GMT-4:00) ADDED BY (B)(6): (B)(4). MAQUET CARDIOPULMONARY AG REQUESTED THE PRODUCT BACK FOR INVESTIGATION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). OXYGENATOR WAS RECEIVED FOR INVESTIGATION BY THE MANUFACTURER. PRODUCT WAS ONLY PACKED IN BAGS WITHIN A CARTON. NO BIOKIT WAS USED. THE OXYGENATOR WAS FIRSTLY CLEANED AND DISINFECTED. BY PERFORMING A VISUAL INSPECTION, CLOTTING IN THE OXYGENATOR WAS NOTICED. DURING TIGHTNESS TEST A CRACK ON DE-AIRING STOP COCK CONNECTOR ON UPPER BLOOD OUTLET SIDE WAS NOTICED. AN ADDITIONAL COMPLAINT WAS OPENED BY THE MANUFACTURER FOR TRACKING AND TRENDING THE FAILURE. FOR PERFORMING FURTHER INVESTIGATION STEPS, THE CRACK ON DE-AIRING STOP-COCK CONNECTOR WAS REPAIRED WITH UV GLUE. WITHOUT GLUING THE PRODUCT, A PRESSURE DROP PERFORMANCE TEST WOULD NOT BE POSSIBLE. OXYGENATOR WAS TESTED FOR ITS PRESSURE DROP PERFORMANCE. THEREBY A PRESSURE DROP DURING MAXIMUM FLOW AT A BLOOD-GAS-RATIO 1:1 MAX. 100 MMHG WAS PERFORMED. OXYGENATOR PASSED SUCCESSFULLY THE PRESSURE TESTING. THEREFORE THE REPORTED FAILURE COULD NOT BE CONFIRMED. THE CAUSE OF THIS FAILURE WAS DETERMINED TO NOT BE ATTRIBUTED TO A DEVICE RELATED MALFUNCTION. FURTHERMORE A DEVICE HISTORY RECORD WAS PERFORMED BY THE MANUFACTURER. THE PRODUCT PASSED EVERY PRODUCTION STEP AND WAS NOT MARKED AS SCRAP. THERE WERE NO REFERENCES FOUND, WHICH ARE INDICATING A NONCONFORMANCE OF THE PRODUCT IN QUESTION. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET TRENDING PROCESS. IF A TREND OCCURS, IT WILL BE ESCALATED TO QUALITY ASSURANCE MANAGEMENT FOR REVIEW AND DETERMINATION OF APPLICABLE INVESTIGATION. DUE TO THIS NO FURTHER ACTION WILL BE COMPLETED AT THIS TIME.

    Description of Event or Problem · 1

    DURING EXTRACORPOREAL CIRCULATION IN THORACIC AORTA ANEURYSM CASE, P2 TURNED TO 350MMHG WHEN GRADUALLY DECREASING BODY TEMPERATURE. ME DOUBTED QUADROX-I. CLOGGING. ME WAS ON BLOOD TRANSMISSION VIA AXILLA WITH ACT 600, THERE IS NO PROBLEM TO OXYGENATION. ME CHANGED QUADROX-I TO NEW ONE BECAUSE FLOW RATE WAS NOT AVAILABLE DUE TO P2 INCREASE. THE PRODUCT WAS REPLACED 1 HOUR 45 MINUTES AFTER INITIATION OF THE TREATMENT. P2 WAS STILL INCREASED, HOWEVER, ME TURNED OFF THE PUMP. OPERATION WAS OVER, THE PATIENT USE PCPS(EMERSAVE, PRODUCT OF TERUMO CORPORATION). FLOW RATE WAS UNDER 1L EVEN USE PCPS. ME CHANGED OXYGENATOR SAME AS QUADROX-I, FLOW RATE WAS NOT AVAILABLE NEITHER. DURATION OF THE TREATMENT IN TOTAL WAS 4 HOURS. PATIENT EXPIRED. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621490 REF.: # 703005384 CUSTOMER REF.: 15-0536 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG HMO 71000-J

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R