BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPIOX FLEXIBLE VENOUS RESERVOIR

    MDR report key: 693145 · Received March 27, 2006

    Report

    Report Number
    1124841-2006-00005
    Event Type
    Death
    Date Received
    March 27, 2006
    Date of Event
    February 27, 2006
    Report Date
    February 27, 2006
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A MITRAL VALVE REPLACEMENT PROCEDURE, THE PERFUSIONIST EXPERIENCED DIFFICULTY IN MAINTAINING ADEQUATE FLOW THROUGH THE VENOUS RESERVIOR BAG. THE CAUSE FOR THIS WAS NOT DETERMINED, BUT THE PERFUSIONIST NOTICED THERE WAS LESS BLOOD BEING RETURNED THAN EXPECTED. IT WAS REPORTED THAT THE PATIENT MAY HAVE HAD AND AN ANAPHYLACTIC REACTION EVIDENCED BY AN ENLARGED/SWOLLEN HEAD AND TONGUE. THE PATIENT WAS TAKEN OFF OF BYPASS AND WAS TRANSFERRED TO ICU. HOWEVER, HE DID NOT REGAIN CONSCIOUSNESS AFTER SURGERY AND LATER EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIOX FLEXIBLE VENOUS RESERVOIR BLOOD RESERVOIR DTN TERUMO CARDIOVASCULAR SYSTEMS CORP. NA FL05

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death