BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1030074 · Received April 15, 2008

    Report

    Report Number
    1423500-2008-00235
    Event Type
    Injury
    Date Received
    April 15, 2008
    Date of Event
    March 31, 2008
    Report Date
    April 3, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE WAS DISCARDED. THE LOT NUMBER IS UNK. BAXTER IS MONITORING ISSUES LIKE THIS. SHOULD ADD'L INFO BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    INITIALLY, THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER ON 3-17-08 REGARDING A SYSTEM ERROR 2240 ALARM THAT APPEARED ON THE HOME CHOICE (HC) DISPLAY DURING AN INITIAL DRAIN. A 2240 ALARM IS AN AIR IN THE ALARM. THE PT LINE WAS NOT CONNECTED TO THE TRANSFER SET BEFORE PRESSING, "GO" TO BEGIN THE INITIAL DRAIN/THERAPY. REPORTEDLY, THERE WAS A LEAK NOTED IN THE TUBING SET. NO PT INJURY OR INTERVENTION WAS REPORTED AT THE TIME OF THIS REPORT. DURING A FOLLOW UP CALL ON 4-3-08 WITH THE HOME PT'S NURSE REGARDING THE SYSTEM ERROR 2240 ALARM, THE NURSE INDICATED THAT THE HOME PT WAS HOSPITALIZED DUE TO PERITONITIS. THE HOSPITAL ADVISED THE HOME PT HAD BEEN HOSPITALIZED IN 2008 WITH ABDOMINAL PAIN AND CLOUDY FLUID. THE HOME PT WAS DIAGNOSED WITH PERITONITIS THE NEXT DAY. THE PT'S CULTURE WAS POSITIVE FOR STAPHYLOCOCCUS AND THE INITIAL WHITE BLOOD COUNT (WBC) WAS 10. CEFTRIAXONE 1GM DAILY WAS ORDERED. THE HOME PT WAS DISCHARGED FROM THE HOSPITAL THE NEXT MONTH. THE PT OUTCOME IS GOOD AND HE HAS RESUMED PD THERAPY. THE NURSE INDICATED THE PERITONITIS WAS REPORTEDLY CAUSED BY POOR ASEPTIC TECHNIQUE. HOWEVER, THE PT IS COMPLIANT WITH THERAPY. REPORTEDLY, THE PT HAS A PET THAT CHEWED ON THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG 78FKX FKX BAXTER HEALTHCARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention