BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGENATOR, CARDIOPULMONARY BYPASS

    MDR report key: 6864898 · Received September 14, 2017

    Report

    Report Number
    8010762-2017-00298
    Event Type
    Malfunction
    Date Received
    September 14, 2017
    Date of Event
    August 31, 2017
    Report Date
    November 6, 2017
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS INVESTIGATED AT THE LABORATORY OF THE MANUFACTURER. NO CLOTS WERE VISIBLE ON THE BLOOD INLET AND BLOOD OUTLET SIDE. NO OTHER ABNORMALITIES WERE DETECTED. AFFECTED PRODUCT: BASIC LOT 70112243 AND PACKAGING LOT 70113498 (SERIAL NUMBER (B)(4). THE AVZ FROM GQW 990 TO GQW 664 (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. TO ENSURE PERFORMANCE OF THE PRODUCTS PRIOR TO SHIPMENT, CHECKS, CONTROLS, AND PERFORMANCE TESTS ARE CARRIED OUT DURING THE MANUFACTURE OF THE PRODUCTS. THESE TESTS CAN BE REVIEWED AS PART OF A DHR REVIEW. THUS THE REPORTED FAILURE COULD NOT BE CONFIRMED. BASED ON THE RESULTS OBTAINED DURING INVESTIGATION AT THIS TIME THE CAUSE OF THE REPORTED INCIDENT WAS DETERMINED TO NOT BE ATTRIBUTED TO A DEVICE RELATED MALFUNCTION.

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER: "DURING TREATMENT THE OXYGENATOR WAS EXCHANGED DUE TO HIGH TRANS MEMBRANE PRESSURE AND BAD OXYGENATION. THE EXCHANGE WAS PERFORMED WITHOUT COMPLICATIONS" (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646998 OXYGENATOR, CARDIOPULMONARY BYPASS OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG HMO 71000 70108074

    Patients

    Seq Age Sex Outcome Treatment
    1