BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE 4 PRONG

    MDR report key: 1202943 · Received October 16, 2008

    Report

    Report Number
    1423500-2008-00863
    Event Type
    Injury
    Date Received
    October 16, 2008
    Date of Event
    September 22, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE WAS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    ON 09/07/08, A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) UNIT DURING DWELL 4 OF 5. AT THE TIME OF THE CALL, THE HOME PT (HP) WAS STILL CONNECTED. THERE WERE NO LEAKS NOTED AND THE BAGS WERE STILL CONNECTED. THE TECHNICAL SERVICE REP (TSR) ASSISTED THE HP TO RESET THE ALARM SO THE HP WAS ABLE TO UNLOAD THE CASSETTE/BAGS. ON 10/08/08, THE NURSE WAS CONTACTED AND STATED THAT SHE WAS AWARE OF THE SYSTEM ERROR 2240 ALARM AND THAT THE HP WAS HAVING A COUPLE OF CASSETTE PROBLEMS. THE NURSE INDICATED THAT THE HP WAS DIAGNOSED WITH PERITONITIS IN 2008, EXHIBITING CLOUDY EFFLUENT. ACCORDING TO THE NURSE, TOUCH CONTAMINATION MAY HAVE BEEN POSSIBLE WHEN THE HP HAD SOME DIFFICULTY WITH 2 CASSETTES DURING A THERAPY ABOUT ONE WEEK PRIOR. HOWEVER, PER THE MEDICAL DIRECTOR'S ASSESSMENT, THE RELOAD SET ALARM WHICH OCCURRED ON THAT DAY, DOES NOT SUGGEST A BREAK IN THE STERILE SYSTEM. INSTEAD, THIS ALARM IS COMMONLY DUE TO THE CASSETTE NOT BEING PROPERLY SEALED IN THE DOOR PRIOR TO CONNECTION TO THE HP. THE HP WAS GIVEN 2 DOSES OF VANCOMYCIN INTRAPERITONEALLY IN-CENTER (NOT HOSPITALIZED), ONE ON THE EVENT DATE AND ANOTHER ABOUT TWO DAYS LATER, AND REPORTEDLY RECOVERED FROM THE PERITONITIS EPISODE AT APPROX FOUR DAYS LATER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention