BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE 4 PRONG

    MDR report key: 1012634 · Received March 11, 2008

    Report

    Report Number
    1423500-2008-00149
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    February 9, 2008
    Report Date
    February 26, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION, SINCE IT HAS BEEN DISCARDED.

    Description of Event or Problem · 1

    A HOME PT RECEIVED A SYSTEM ERROR 2240 ALARM. UPON INVESTIGATION OF THIS REPORT, THE NURSE REPORTED, THAT THE HOME PT HAD PERITONITIS. THE HOME PT'S NURSE REPORTED, THAT THE HOME PT WAS DIAGNOSED WITH PERITONITIS IN 2008. THE HOME PT WENT TO THE ER DUE TO ABDOMINAL PAIN AND CLOUDY EFFLUENT AND WAS ADMITTED INTO THE HOSPITAL THE SAME DAY. THE CULTURE TAKEN PRIOR TO EVENT, REVEALED, METHICILLIN RESISTANT STAPHYLOCOCCUS EPIDERMIS. THE HOME PT WAS TREATED WITH VANCOMYCIN, STARTING IN THE HOSPITAL, WHICH THE NURSE DID NOT KNOW THE DOSAGE. THE HOME PT COMPLETED TREATMENT AT HOME WITH 2G VANCOMYCIN ONCE A WEEK FOR 3 WEEKS. THE NURSE STATED, THAT THE HOME PT HAS RECOVERED AS OF THE FOLLOWING THREE WEEKS. THERE WAS NO KNOWN EXIT SITE INFECTION. THE HOME PT HAD A SYSTEM ERROR 2240 ALARM AS A RESULT OF ACCIDENTALLY LEAVING AN UNUSED CLAMP OPEN. A PD EFFLUENT CULTURE WAS TAKEN AND THE RESULTS WERE FINALIZED THIRTEEN DAYS EARLIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE 4 PRONG 78FKX FKX BAXTER HEALTHCARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R