BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGENATOR, CARDIOPULMONARY BYPASS

    MDR report key: 6672779 · Received June 28, 2017

    Report

    Report Number
    8010762-2017-00205
    Event Type
    Malfunction
    Date Received
    June 28, 2017
    Date of Event
    June 6, 2017
    Report Date
    September 21, 2017
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS VISUALLY INSPECTED IN THE LABORATORY OF THE MANUFACTURER. ON THE BLOOD INLET AND OUTLET SIDE NO CLOTS WERE DETECTED. DURING RINSING NO CLOTS WERE FLUSHED OUT. THE PRODUCT WAS CLEANED WITH SODIUM HYPOCHLORITE SOLUTION. NO OTHER ABNORMALITIES WERE DETECTED. FOR FURTHER EXAMINATION ALL FOUR SIDES OF THE OXYGENATOR WERE SAWN OPEN, AND THE MATS WERE INSPECTED FOR ANY SIGNS OF DAMAGE, MARKS OR ANY OTHER ANOMALIES. NO ABNORMALITIES WERE FOUND. THE NUMBER OF GAS MATS WAS ALSO COUNTED, AND THERE ARE 74 MATS ON THE GAS SIDE AND 23 MATS ON THE SIDE OF THE HEAT-EXCHANGER THIS IS WITHIN SPECIFICATION. THERE WERE NO SIGNS OF ANY CLOTTING BETWEEN THE MATS, OR ANYTHING ELSE OF NOTE. THUS THE REPORTED FAILURE COULD NOT BE CONFIRMED. DHR REVIEW:AFFECTED PRODUCT: BASIC LOT 70113490 AND PACKAGING LOT 70113491 (SERIAL NUMBER (B)(4)). THE AVZ FROM GGX 600 TO GGX 614 (B)(4) WAS REVIEWED ON (B)(6) 2017. THERE WERE NO REFERENCES FOUND, WHICH ARE INDICATING A NONCONFORMANCE OF THE PRODUCT IN QUESTION. ADDITIONALLY A REVIEW OF THE WEEKLY PERFORMANCE MONITORING ACCORDING TO SI-C-09 HAS BEEN REVIEWED (B)(4), THE PERFORMANCE TESTS PASSED THE ACCEPTANCE CRITERIA. 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.

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER: THE CUSTOMER USED HMO71000 FOR THE SURGERY OF THE REPLACEMENT OF DESCENDING THORACIC AORTA THE EXTRACORPOREAL CIRCULATION WAS STARTED. (AFTER 6 HOURS) THE CUSTOMER OBSERVED THAT THE PO2 WAS LOW (105). THE CUSTOMER INCREASED FIO2 FROM 50% TO 80%. PO2 EXCEEDED 300. THE CUSTOMER OBSERVED THE PO2 WAS LOW (21). THE CUSTOMER INCREASED FIO2 TO 100% AND THEN, PO2 EXCEEDED 100. THE CUSTOMER INCREASED THE GAS FLOW TO10L. P02 DID NOT GO UP MORE THAN 100. THE EXTRACORPOREAL CIRCULATION WAS FINISHED. -NO ADVERSE EFFECTS ON THE PATIENT -THE PRODUCT WILL BE DELIVERED TO MCP (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456419 OXYGENATOR, CARDIOPULMONARY BYPASS OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG HMO 71000-J 70113491

    Patients

    Seq Age Sex Outcome Treatment
    1