BEUDAMED
    FDA Adverse Event Summary report: N

    CENTURY 3

    MDR report key: 34559 · Received May 24, 1996

    Report

    Report Number
    34559
    Date Received
    May 24, 1996
    Date of Event
    May 4, 1996
    Report Date
    May 6, 1996
    Manufacturer
    COBE RENAL CARE, INC.
    Product Code
    FII
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WHILE TREATMENT WAS IN PROGRESS THE MACHINE ALARMED AIR IN BLOOD. UPON INSPECTION MICROBUBBLES WERE NOTED IN THE VENOUS SIDE OF THE PT'S CATHETER AND FOAM WAS NOTED IN THE VENOUS CHAMBER OF THE CARTRIDGE. PT C/O SOB, CHEST PAIN, DIAPHORESIS, LOW BP AND TACHYCARDIA. PT PLACED ON LEFT SIDE IN TRENDELBURG POSITION, TREATMENT DISCONTINUED, DR. NOTIFIED, O2 AND SALINE GIVEN. PT TRANSPORTED TO LOCAL HOSP WHERE HE WAS EVALUATED AND RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTURY 3 C3 FII COBE RENAL CARE, INC. CS3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR