BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE - 4 PRO

    MDR report key: 1290768 · Received January 16, 2009

    Report

    Report Number
    1423500-2009-00035
    Event Type
    Death
    Date Received
    January 16, 2009
    Date of Event
    November 22, 2008
    Report Date
    November 22, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR CODE 2367 THAT OCCURRED ON THE HOME CHOICE (HC) DURING DRAIN 4 OF 6. THIS SYSTEM ERROR IS A CASCADING ERROR THAT OCCURS AFTER A SYSTEM ERROR 2240 (AIR IN LINE) ALARM. THE HOME PATIENT (HP) HAD DISCONNECTED DURING DWELL, RETURNED AFTER THE MACHINE MOVED TO DRAIN, RECONNECTED, AND THE ALARM OCCURRED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED CLEARING THE ALARM AND REFERRED THE HOME PATIENT (HP) TO THE PERITONEAL DIALYSIS NURSE. THE HP WAS TO COMPLETE THERAPY WITH MANUAL SUPPLIES. THE HC UNIT WAS OPERATIONAL. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW-UP CALL TO THE NURSE IN 2008, THE NURSE STATED THE HP WAS ADMITTED TO THE HOSPITAL IN 2008 WITH PERITONITIS. THE PATIENT THEN PASSED AWAY AT ABOUT 25 DAYS LATER FROM SEPSIS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET W/CASSETTE - 4 PRO 78FKX FKX BAXTER HEALTHCARE NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death| H