BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1243943 · Received November 25, 2008

    Report

    Report Number
    1423500-2008-00945
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    October 25, 2008
    Report Date
    October 25, 2008
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2008, A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM DURING DWELL 3 OF 6 WHILE USING THE HOME CHOICE DEVICE. THE CAREGIVER NURSE STATED THAT A BAG CAME UNHOOKED WHEN IT FELL. THE TECHNICAL SERVICE REP (TSE) EXPLAINED THE ALARM TO THE CAREGIVER. THE CAREGIVER ALREADY HAD A NEW SET OF SUPPLIES WAITING AND WANTED TO REMOVE THE CURRENT SET-UP. THE TSR ASSISTED THE CAREGIVER IN DOING SO. ON THE FOLLOWING MONTH, THE PERITONEAL DIALYSIS (PD) NURSE WAS CONTACTED AND STATED THAT THE HOME PT (HP) PRESENTED WITH A CLOUDY EFFLUENT BAG AND DEVELOPED PERITONITIS ON THREE DAYS AFTER THE ORIGINAL MONTH; HOWEVER, THE HP WAS NOT HOSPITALIZED. THERE WAS NO EXIT SITE OR TUNNEL INFECTION. THE NURSE ASSUMED THAT THE PERITONITIS WAS CAUSED BY A BREAK IN THE CAREGIVER'S ASEPTIC TECHNIQUE. THE PD NURSE INDICATED THAT THE CAREGIVER WAS A NEW NURSE AT THE NURSING HOME WHERE THE HP IS STAYING. A CELL COUNT WAS PERFORMED ON THAT DAY, BUT THE RESULTS WERE UNAVAILABLE. A CULTURE WAS ALSO TAKEN OF THE EFFLUENT THE SAME DAY, AND COAGULASE-NEGATIVE STAPHYLOCOCCUS WAS IDENTIFIED. THE HP WAS GIVEN ONE GRAM OF VANCOMYCIN INTRAPERITONEAL BEGINNING ON 10/28/08, FOR A DURATION OF THREE WEEKS. DURING AN ADDITIONAL FOLLOW-UP CALL TO THE HP'S PD NURSE THE FOLLOWING MONTH, THE NURSE INDICATED THAT THE CIRCUMSTANCES SURROUNDING THE BAG FALLING AND BECOMING DISCONNECTED ARE UNK. THE NURSE ALSO STATED THE BAG FALLING AND BECOMING DISCONNECTED ARE UNK. THE NURSE ALSO STATED THAT A RE-TRAINING IN-SERVICE WILL BE CONDUCTED ON ASEPTIC TECHNIQUE AT THE HP'S NURSING HOME FOR NURSES THERE. THE NURSE THEN INDICATED THAT THE HP HAS RECOVERED FROM THIS EPISODE OF PERITENONITIS, IS DOING WELL, AND HAS BEEN ABLE TO CONTINUE WITH PD THERAPY WITHOUT ANY FURTHER PROBLEMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention