BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UV FLASH AUTO

    MDR report key: 413462 · Received August 20, 2002

    Report

    Report Number
    1423500-2002-01061
    Event Type
    Injury
    Date Received
    August 20, 2002
    Date of Event
    July 22, 2002
    Report Date
    July 30, 2002
    Manufacturer
    MEDI-TECH, INC.
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BAXTER COMPLAINT COORDINATOR REPORTED THE HOME PT (HP) SUSPECTED PERITONITIS AFTER USING THE UF FLASH AUTO DEVICE FOR CAPD THERAPY. THE HP WENT TO THE HOSP AND THEIR EFFLUENT WAS TESTED, WHICH REVEALED AN INCREASED PLATELET LEVEL. THE HP WAS HOSPITALIZED THE NEXT DAY AND WAS TREATED WITH CEFAZOLIN AND TOBRAMYCIN FOR 7 DAYS. THE RESULTS OF THE CULTURE OF EFFLUENT REVEALED STREPTOCOCCUS BACTERIA, AFTER WHICH THE HP WAS TREATED WITH TOBRAMYCIN ONLY. THE HP HAS SINCE RECOVERED BUT REMAINS HOSPITALIZED AS OF 8/2002. THE UVFLASH AUTO DEVICE WAS NOTED TO HAVE PEELING OF THE REFLECTIVE METAL SURFACE, WHICH REFLECTS THE ULTRAVIOLET LIGHT EMITTED BY THE DEVICE DURING AN EXCHANGE. THE HP'S PHYSICIAN SUSPECTED A LACK OF RADIATION MAY HAVE CONTRIBUTED TO THE PERITONITIS EPSIODE AND A DEVICE EVAL WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UV FLASH AUTO UV-FLASH KDJ MEDI-TECH, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R DIANEAL.