BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2821494 · Received November 6, 2012

    Report

    Report Number
    1416980-2012-04189
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 18, 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) WAS CONFIRMED AND THE ROOT CAUSE WAS DETERMINED TO BE A USE ERROR DUE TO AN OPEN CLAMP. 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. THE LOT NUMBER WAS UNKNOWN; THEREFORE NO BATCH REVIEW COULD BE PERFORMED.

    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. THE HOME PATIENT (HP) DID NOT CLOSE THE CLAMP ON THE FINAL LINE THAT IS NOT IN USE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD HP CYCLE POWER AND SE 2367 ALARMED. THE TSR HAD HP DISCONNECT. THE HP WOULD COMPLETE THERAPY USING MANUAL SUPPLIES. 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
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR HOMECHOICE