BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UV-FLASH SOLUTION TRANSFER SET (SHORT) - JAPAN

    MDR report key: 1192389 · Received October 6, 2008

    Report

    Report Number
    1423500-2008-00857
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 16, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS UNAVAILABLE.

    Description of Event or Problem · 1

    IN 2008, BAXTER WAS NOTIFIED THAT THE SPIKE SEPARATED FROM THE SPIKE PORT ON A TRANSFER SET. AFTER THE DISCONNECTION, THE PT CONNECTED TO THE SPIKE TO ANOTHER SOLUTION BAG WITHOUT ULTRA VIOLET IRRADIATION AND WITHOUT USING THE SHELL CONNECTOR. THE PT PRESENTED WITH CLOUDY DIALYSATE AND WAS DIAGNOSED WITH PERITONITIS AND HOSPITALIZED ON A WEEK PRIOR TO ORIGINAL DATE. THE PT WAS TREATED WITH PANSPORIN (CEFOTIAM HYDROCHLORIDE) 2 GRAM/VIAL ONCE PER DAY INTRAVENOUS STARTING ON THAT DAY FOR NINE DAYS, PANSPORIN (CEFOTIAM HYDROCHLORIDE) 1 GRAM/VIAL 3 TIMES PER DAY INTRAVENOUS DURING THAT PERIOD, RIFADIN (RIFAMPICIN), 3 CAPSULES PER DAY ORAL STARTING ON TWO DAYS AFTER THE ORIGINAL DATE AND CEFZON (CEFDINIR), 2 CAPSULES PER DAY ORAL STARTING ON THAT DAY. THE PT WAS RELEASED FROM THE HOSPITAL ON ORIGINAL DATE, WHEN THE PERITONITIS WAS CURED. THE PT HAD A BREAK IN ASPECT TECHNIQUE AND WAS RETRAINED ON PROPER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UV-FLASH SOLUTION TRANSFER SET (SHORT) - JAPAN 87KDJ KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R