BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1153283 · Received September 8, 2008

    Report

    Report Number
    1423500-2008-00792
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    July 28, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS DISCARDED.

    Description of Event or Problem · 1

    IN 2008, A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICE CTR REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM DURING DWELL 3/6 WHILE USING THE HOME CHOICE SYSTEM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM TO THE NURSE. THE TSR HAD THE NURSE CLOSE ALL CLAMPS, CYCLE POWER OFF/ON, AND SYSTEM ERROR 2367 WAS REC'D. THE TSR HAD THE NURSE CYCLE POWER OFF/ON, AT LOAD THE SET. THE HOME PATIENT (HP) WOULD DISCARD THE OLD SUPPLIED/CASSETTE, END THERAPY AND CONTACT THE PERITONEAL DIALYSIS (PD) NURSE THE FOLLOWING MORNING. ON THE FOLLOWING MONTH, THE NURSE WHO REPORTED THE 2240 ALARM WAS CONTACTED AND STATED THAT ONE OF THE SUPPLY BAGS SEEMED TO HAVE A LOT OF AIR IN IT, BUT DID NOT NOTICE ANY HOLES OR LEAKS IN THE BAG OR TUBING SET. THE NURSE FURTHER STATED THAT THE HP HAD PERITONITIS, WAS GOING TO HAVE THE CATHETER TAKEN OUT AND TRANSITION TO HEMODIALYSIS. ON 08/19/08, GLOBAL PHARMOCOVIGILANCE CONTACTED THE PD NURSE AND OBTAINED THE FOLLOWING INFO: THE PD CATHETER WAS REMOVED ON THIRTEEN DAYS EARLIER, DUE TO PERITONITIS, AND THE HP WAS SWITCHED TO HEMODIALYSIS. THE HP WAS HOSPITALIZED ON FIVE DAYS LATER TO HAVE HIS GALL BLADDER REMOVED ON TWO DAYS LATER. A CULTURE WAS TAKEN AND KLEBSIELLA WAS THE ORGANISM IDENTIFIED. THE HP ALSO HAD AN EXIT SITE/TUNNEL INFECTION. THE NURSE STATED THAT THERE WAS A BREAK IN ASEPTIC TECHNIQUE WHEN THE TRANSFER SET BROKE TWICE DURING (PD) THERAPY. ACCORDING TO THE NURSE, THE HP HAS HAD PERITONITIS WITHIN FOUR WEEKS OF THIS REPORT (DATE UNKNOWN), AND THE CULTURE RESULTS REVEALED A YEAST INFECTION. THE PD NURSE DID NOT KNOW WHAT MEDICATIONS WERE GIVEN TO THE HP. THE HP IS CURRENTLY RECOVERING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R