BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPIOX SX18 OXYGENATOR

    MDR report key: 290705 · Received August 16, 2000

    Report

    Report Number
    1124841-2000-00005
    Event Type
    Death
    Date Received
    August 16, 2000
    Date of Event
    July 7, 2000
    Report Date
    July 27, 2000
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WITHIN 5 MINUTES OF INITIATING A PROCEDURE TO "RE-DO" A TRICUPSID VALVE, THE PT'S BLOOD PRESSURE SUDDENLY INCREASED TO ABOVE 200-MMHG. THE CAUSE FOR THIS WAS NOT DETERMINED, BUT THE BP WAS BROUGHT UNDER CONTROL AND THE OPERATION WAS COMPLETED WITHOUT FURTHER DIFFICUTLY. THE PT WAS TAKEN OFF OF BYPASS AND REMOVED FROM THE OPERATING ROOM WITH NO APPARENT PROBLEMS. HOWEVER, HE DID NOT REGAIN CONSCIOUSNESS AFTER SURGERY AND LATER EXPIRED. AN AIR BOLUS WAS FOUND IN THE BRAIN ON AUTOPSY. THE CHIEF PERFUSIONIST STATED THAT THERE WAS NO INDICATION OF A PRODUCT RELATED CAUSE FOR THIS EVENT AND THERE WAS NO OPPORTUNITY FOR THE AIR TO HAVE ENTERED BY WAY OF THE OXYGENATOR OR THE EXTRACORPOREAL CIRCUIT (THE RESERVOIR LEVEL NEVER DROPPED, A LEVEL SENSOR WAS USED AND THE ARTERIAL FILTER WAS ON CONTINOUS PURGE). ALSO, BECAUSE THE EVENT WAS NOT IDENTIFIED UNTIL WELL AFTER THE PROCEDURE HAD BEEN COMPLETED, ALL OF THE DEVICES USED HAD ALREADY BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIOX SX18 OXYGENATOR OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death