BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE INTEGRATED APD SETWITH CASSETTE 3-PRONG

    MDR report key: 1212945 · Received October 29, 2008

    Report

    Report Number
    1423500-2007-88870
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    June 28, 2007
    Report Date
    June 28, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM THE FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA JULY 27, 2007.

    Description of Event or Problem · 1

    A HOME PATIENT CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 MESSAGE THAT APPEARED ON THE DISPLAY OF THE HOME PATIENT'S HOMECHOICE MACHINE DURING THEIR AUTOMATED PERITONEAL DIALYSIS THERAPY. HP STATES PATIENT LINE BECAME DISCONNECTED FROM PATIENT AND THEN MACHINE ALARMED SE2240. TSR HAD HP CLOSE ALL CLAMPS, CYCLE POWER TO SE2367 AND THEN TO PRESS GO TO START. TSR EXPLAINED HP ALARMS AND ADVISED HIM TO START OVER WITH NEW SUPPLIES DUE TO POSSIBLE CONTAMINATON IN LINES. TSR ALSO SUGGESTED HP TO CALL BACK FOR HELP BYPASSING DAY CYCLE. HC OK. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. THIS WRITER CONTACTED THE HOME PATIENT¿S NURSE, WHO WAS MADE AWARE OF THIS INCIDENT. THE NURSE STATED THAT SHE HAD SEEN THE PATIENT IN THE CLINIC A COUPLE OF TIMES SINCE THE ALARM AND CONFIRMED THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE INTEGRATED APD SETWITH CASSETTE 3-PRONG 78FKX FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1