BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT

    MDR report key: 341766 · Received July 12, 2001

    Report

    Report Number
    341766
    Event Type
    Other
    Date Received
    July 12, 2001
    Date of Event
    July 1, 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 WAS RECEIVING A BLOOD TRANSFUSION. BLOOD ENTERED & PT SYSTEM AT 1315. RN CHECKED URINE PRIOR TO START OF TRANSFUSION AND CHECKED IT WITH DIPSTICK WHICH WAS NEGATIVE FOR BLOOD. RN WAS IN PT ROOM FOR FINISH 15 MINS (50CC BLOOD) & CHECKED URINE EVERY 30 MINS. AT 1445 SLIGHT TEMP ELEVATION FROM 97.4 TO 99 F DEGREES. CHECKED URINE FOR BLOOD AT 1455 (3+ BLOOD). TRANSFUSION STOPPED. TUBING SENT TO LAB WITH BLOOD. THIS WAS SECOND INCIDENT/DIFFERENT LOT IN ONE WEEK. THE DEVICE FILTER WAS AT FAULT IN THE PRIOR EVENT. ALL BLOOD TUBING OF THIS LOT SENT BACK TO MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31755 ABBOTT Y-TYPE BLOOD SET-OL BRZ ABBOTT * 69105.HG01

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other