BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2910371 · Received January 11, 2013

    Report

    Report Number
    1416980-2013-00857
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR (SE) 2240 (AIR IN SET) IS CONFIRMED AND THE ROOT CAUSE WAS DETERMINED TO BE A CLAMP WAS OPEN ON AN UNUSED SUPPLY LINE DURING THERAPY. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR (SE) 2240 ON THE HOME CHOICE (HC) DURING DWELL 1 OF 3. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM TO THE HOME PATIENT (HP). THE HP STATED THEY LEFT AN UNUSED LINE CLAMP OPEN DURING THERAPY. THE TSR THEN EXPLAINED THAT THE SUPPLIES ARE COMPROMISED AND THE HP WILL NEED TO START OVER WITH NEW SUPPLIES. THE TSR THEN ADVISED THE HP TO MAKE SURE ANY UNUSED LINES ARE CLOSED DURING THERAPY. THE TSR ADVISED THE HP TO CALL THEIR REGISTERED NURSE (RN) IN THE NEXT 24 HOURS AND LET HER KNOW WHAT HAPPENED. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE HP. THE HC WAS OPERATIONAL AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18876 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR HOMECHOICE