BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGNATURE CUSTOM PERFUSION SYSTEMS

    MDR report key: 203541 · Received December 18, 1998

    Report

    Report Number
    203541
    Event Type
    Death
    Date Received
    December 18, 1998
    Date of Event
    December 8, 1998
    Report Date
    December 18, 1998
    Manufacturer
    AVECOR CARDIOVASCULAR, INC.
    Product Code
    DWB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AIR WAS ASSUMED TO HAVE BEEN INFUSED INTO THE AORTIC ROOT VIA THE AORTIC VENT LINE WHILE PT WAS ON CARDIOPULMONARY BYPASS 12/8/98. VENT LINE ASSEMBLED INCORRECTLY BY MFR. PT EXPERIENCED A CEREBRAL AIR EMBOLUS AND EXPIRED 12/9/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNATURE CUSTOM PERFUSION SYSTEMS BYPASS PUMP PACK DWB AVECOR CARDIOVASCULAR, INC. 1120B-05-PUMP PACK CP98124E

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death