BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UV-FLASH SOLUTION TRANSFER SET (SHORT) - JAPAN

    MDR report key: 1173444 · Received September 23, 2008

    Report

    Report Number
    1423500-2008-00807
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 3, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    PMA / PMN Number
    K883239
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS RETURNED FOR EVALUATION. EVALUATION RESULTS FROM FROM ANOTHER COUNTRY, INDICATE: A 1 MM CRACK WAS DETECTED AT 23 CM FROM THE TWIST CLAMP BY THE UNDERWATER LEAK TEST AT 8 PSI FOR 10 SECONDS. THE REPORTED DEFECT WAS CONFIRMED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A MALE PT WHO WAS HOSPITALIZED FOR PERITONITIS ON AN UNK DATE AFTER EXPERIENCING A LEAKING TRANSFER SET AFTER 120 DAYS OF USE. A CULTURE WAS TAKEN IN 2008, OF CLOUDY DIALYSATE WHICH RETURNED POSITIVE. THE PT REPORTEDLY HAD A CULTURE AND SENSITIVITY DRAWN (DATE UNK) WITH RESULTS OF METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS. THE PT WAS TREATED WITH VANCOMYCIN AND TEICOPLANIN (DOSE, RATE AND CONCENTRATION UNK) INTRAVENOUS FOR AN UNK LENGTH OF THERAPY. THE PT OUTCOME IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UV-FLASH SOLUTION TRANSFER SET (SHORT) - JAPAN 78KDJ KDJ BAXTER HEALTHCARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R DIANEAL-N