BEUDAMED
    FDA Adverse Event Other Summary report: N

    CATS

    MDR report key: 286444 · Received July 17, 2000

    Report

    Report Number
    3033270-2000-00001
    Event Type
    Other
    Date Received
    July 17, 2000
    Date of Event
    June 23, 2000
    Report Date
    July 17, 2000
    Manufacturer
    FRESENIUS MEDICAL CARE / PLANT SCHWEINFURT
    Product Code
    CAC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN ALLEGES THAT ONE HOUR AFTER THE PT RECEIVED PACKED RED CELLS, WHICH WERE PROCESSED WITH CATS' (CONTINUOUS AUTO TRANSFER SYSTEM), DURING ORTHOPEDIC "OR" PT'S URINE TURNED DARK. THE NEXT DAY THE PT ENDED UP ON DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATS CONTINUOUS AUTO TRANSFER SYSTEM (CELL SAVER) CAC FRESENIUS MEDICAL CARE / PLANT SCHWEINFURT CATS KLT221

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR