BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2844874 · Received November 26, 2012

    Report

    Report Number
    1416980-2012-05807
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED OPERATIONAL. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. THE ROOT CAUSE FOR THE REPORTED IIPV WAS DETERMINED TO BE INSUFFICIENT DRAIN, FALSE EMPTY DETECT AND USE ERROR, INITIAL DRAIN ALARM SETTING INAPPROPRIATELY PROGRAMMED. NO FAILURE OR MALFUNCTION WAS IDENTIFIED WITH THE DEVICE THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. THE DEVICE WAS DETERMINED TO MEET SPECIFICATIONS FOR THE REPORTED DIFFICULTY OF AN IIPV. REVIEW OF THE DEVICE LOGS CONFIRMED THE REPORTED INCREASED INTRA-PERITONEAL VOLUME (IIPV). A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE 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 BAXTER TECHNICAL SERVICES (BTS) REGARDING ASSISTANCE WITH INCREASED INTRA-PERITONEAL VOLUME DURING DWELL 1. THIS OCCURRED WHILE THE PATIENT WAS ON THE HOMECHOICE (HC). THE CAREGIVER (CG) STATED THAT THE HOME PATIENT (HP) HAD A MANUAL FILL OF 1500ML BEFORE THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE(TSR) CONFIRMED WITH THE CG THAT THE INITIAL DRAIN VOLUME WAS 111ML. THE TSR ALSO CONFIRMED THE INITIAL DRAIN ALARM WAS SET TO 0ML. THE TSR ASSISTED THE CG TO PERFORM A MANUAL DRAIN OF 2897ML. THEREFORE, THIS EVENT MEETS INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA, WHICH IS ANY THERAPY WHERE THE PATIENT VOLUME EXCEEDS 160% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME. THE CG WANTED TO RESUME THERAPY. THE NURSE WAS CONTACTED ON (B)(4) 2012. THE NURSE CONFIRMED THAT THE HP'S LARGEST PRESCRIBED FILL VOLUME IS 1500ML. THE NURSE STATED THIS WAS AN ISOLATED EVENT. THE NURSE STATED THAT THE HP DID NOT DEVELOP ANY ADVERSE REACTIONS OR REQUIRE ANY MEDICAL INTERVENTION. THE NURSE STATED THAT THE HP DID NOT REPORT ANY FURTHER ISSUES AND THEY WERE CURRENTLY PERFORMING THERAPY WITHOUT ANY COMPLICATIONS. THERE WAS PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE