BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFINITY NT HOLLOW FIBER OXYGENATOR

    MDR report key: 2142323 · Received June 20, 2011

    Report

    Report Number
    2184009-2011-00040
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K932252
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHOD: DEVICE HISTORY REVIEW AND ANALYSIS ARE PENDING. RESULTS: DEVICE HISTORY REVIEW AND DEVICE ANALYSIS ARE PENDING. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: DEVICE ANALYSIS AND DEVICE HISTORY REVIEW ARE PENDING. CONCLUSION: BASED ON THE LIMITED INFORMATION AVAILABLE AT THIS TIME, THE CAUSE FOR THIS EVENT CANNOT BE DETERMINED. UPON FURTHER INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING A BYPASS PROCEDURE, HIGH PRE-MEMBRANE OXYGENATOR PRESSURES WERE OBSERVED DURING CARDIOPLEGIA INFUSION. AS A RESULT OF THE HIGH PRESSURES, FLOW TO THE PATIENT WAS REDUCED. DUE TO THE PERFORMANCE OF THE OXYGENATOR, THE TUBING AND OXYGENATOR WERE CHANGED OUT (WHICH TOOK APPROXIMATELY 2 MINUTES), AND THE PATIENT WAS AGAIN RECOOLED AT 33 TO RESTART BYPASS. A NEW OXYGENATOR OF THE SAME LOT WAS USED AND THE REST OF THE PROCEDURE RAN IN NORMAL FASHION. POST-OPERATIVELY, A MRI WAS PERFORMED WHICH DETECTED CEREBRAL INJURIES, AND HEMIPARESIS OF THE LEFT ARM AND LEG. IT WAS ALSO REPORTED THAT THE PATIENT HAD NOT WOKEN UP COMPLETELY, BUT DID RESPOND TO STIMULUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY NT HOLLOW FIBER OXYGENATOR DTZ MEDTRONIC PERFUSION SYSTEMS 511 11183324

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention