BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED APO SET W/CASSETTE 3-PRONG

    MDR report key: 1041161 · Received May 12, 2008

    Report

    Report Number
    1423500-2008-00332
    Event Type
    Injury
    Date Received
    May 12, 2008
    Date of Event
    February 9, 2008
    Report Date
    April 14, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE WAS DISCARDED AND THE LOT NUMBER IS NOT KNOWN, THEREFORE NO COMPANION SAMPLES WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    DURING A FOLLOW UP CALL REGARDING THE 2367 ALARM DOCUMENTED, A CASE OF PERITONITIS WAS REPORTED. A PERITONITIS WORKSHEET WAS COMPLETED. THE ALARM (SOFTWARE ISSUE) OCCURRED IN 2008, WHEN A SUPPLY BAG FELL OFF THE PT'S SETUP AND BECAME DISCONNECTED. THE PT WAS GIVEN A LOADING DOSE OF VANCOMYCIN 2GRAMS AND CEFAZOLIN 2GRAMS ON THE NEXT DAY BY THE CLINIC AND PRIOR TO HOSPITALIZATION. THE PT WAS ADMITTED TO THE HOSPITAL AND CULTURED POSITIVE FOR METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) ON THE SAME DAY. THE NURSE DID NOT KNOW THE ROOT CAUSE OF THE PERITONITIS. THE PT HAS SINCE RECOVERED FROM THE PERITONITIS AND WAS DISCHARGED FROM THE HOSPITAL ON THE FOLLOWING MONTH. THE PT HAS BEEN TAKEN OFF PERITONEAL DIALYSIS (PD) AND IS CURRENTLY ON HEMODIALYSIS. THE PERITONEAL CATHETER HAS BEEN REMOVED, AND THE PT REMAINS ON HEMODIALYSIS THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APO SET W/CASSETTE 3-PRONG 78FKX FKX BAXTER HEALTHCARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R