BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT

    MDR report key: 342277 · Received July 12, 2001

    Report

    Report Number
    342277
    Event Type
    Other
    Date Received
    July 12, 2001
    Date of Event
    June 27, 2001
    Report Date
    July 3, 2001
    Manufacturer
    ABBOTT
    Product Code
    BRZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT RECEIVING 2ND UNIT OF DONOR BLOOD. TRANSFUSION WAS STARTED AT 0300. TEMP NORMAL. DURING FIRST SEVERAL HOURS OF TRANSFUSION. DAY RN WENT TO CHECK ON PT AT 0650-NOTED THAT URINE COLOR DARK RED. BP WAS INCREASED TO 208/98: URINALYSIS CHECKED (FOR BLOOD). MD NOTIFIED. TRANSFUSION STOPPED. URINALYSIS SPECIMEN TO LAB AND LAB ALSO NOTIFIED. LABS FOR HEMOLYSIS-FILTER TUBING SENT OUT FOR INVESTIGATION. RESULTS CAME BACK. SITE OF HEMODIALYSIS WAS THE BLOOD TUBING FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31574 ABBOTT Y-TYPE BLOOD SET - OL BRZ ABBOTT * NOT KNOWN-SENT OUT

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other