BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1033780 · Received April 25, 2008

    Report

    Report Number
    1423500-2008-00282
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 26, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE WAS DISCARDED BY THE HOME PATIENT. THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    INITIALLY, A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 ALARM THAT APPEARED ON THE HOME CHOICE (HC) DISPLAY DURING DWELL 3 OF 4. THE HOME PATIENT FOUND A LEAK IN THE BAG. THE HOME PATIENT STATED THAT HE HAD A HARD TIME SPIKING THE BAG. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) IN ENDING THERAPY AND ADVISING THE HOME PATIENT TO LET THE RN KNOW. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. IN A FOLLOW UP, IT WAS INDICATED BY THE HOME PATIENT'S NURSE THAT THE HOME PATIENT DEVELOPED PERITONITIS THREE DAYS AFTER THIS REPORT. THE HOME PATIENT WAS NOT ADMITTED TO THE HOSPITAL. THE HOME PATIENT'S SYMPTOMS WERE, CLOUDY EFFLUENT AND ABDOMINAL PAIN. THE RESULTS OF THE CULTURE THAT WAS TAKEN IN 2008, SHOWED STAPHYLOCOCCUS EPIDERMIDIS AND THE WHITE BLOOD COUNT WAS 2500. THE HOME PATIENT WAS GIVEN 1 GRAM OF VANCOMYCIN AND 1 GRAM OF FORTAZ IN THE CLINIC AND THEN THAT EVENING AT HOME THE HOME PATIENT WAS GIVEN 250 MG OF FORTAZ PER ONE LITER OF SOLUTION. THE NEXT DAY THE HOME PATIENT WAS TAKEN OFF OF THE FORTAZ. THE HOME PATIENT WAS GIVEN 1 GRAM OF VANCOMYCIN TWO TIMES IN THE SAME MONTH. A REPEAT BLOOD COUNT WAS TAKEN ON THE SECOND DAY AND THE WHITE BLOOD COUNT WAS 5. THE HOME PATIENT WAS GIVEN A CXD DEVICE TO HELP SPIKE HIS BAGS AS THE REASON THE HOME PATIENT WAS BELIEVED TO HAVE GOTTEN PERITONITIS WAS FROM PUNCTURING A HOLE IN THE SOLUTION BAG WHEN SPIKING IT.

    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 Required Intervention