BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2863581 · Received December 10, 2012

    Report

    Report Number
    1416980-2012-06813
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 17, 2012
    Report Date
    November 17, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). HOMECHOICE WAS RETURNED FOR DEVICE EVALUATION FOR THE REPORTED ISSUE OF INCREASED INTRA-PERITONEAL VOLUME (IIPV). THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. THE REPORTED ISSUE WAS CONFIRMED IN THE DEVICE LOGS BUT NOT DUPLICATED DURING PAL EVALUATION. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. DEVICE MEETS SPECIFICATION FOR THE REPORTED ISSUE OF IIPV-ADULT. 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. THE CAUSE WAS DETERMINED TO BE FALSE EMPTY DETECT AND USE ERROR WITH INITIAL DRAIN ALARM SETTING INAPPROPRIATELY PROGRAMMED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    A REGISTERED NURSE (RN) CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING A HIGH DRAIN 101/CALL PD NURSE ALARM (INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME, MEETING INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA), WHICH OCCURRED ON THE HOME CHOICE PRO (HCP) AFTER USE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE THERAPY LOG. THE INITIAL DRAIN VOLUME WAS EQUAL TO 17ML, THE LAST FILL VOLUME WAS EQUAL TO 18ML, THE TOTAL FILL VOLUME WAS EQUAL TO 9596ML, THE TOTAL DRAIN VOLUME WAS EQUAL TO 12888ML, THE TOTAL ULTRAFILTRATION (UF) WAS EQUAL TO 3292ML, THE CYCLE 4 UF WAS EQUAL TO 155ML, THE CYCLE 3 UF WAS EQUAL TO 493ML, THE CYCLE 2 UF WAS EQUAL TO -50ML, AND THE CYCLE 1 UF WAS EQUAL TO 2694ML. THERE WERE NO BYPASSES DURING THERAPY. THE THERAPY WAS SET TO CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD), THE TOTAL VOLUME WAS SET TO 10500ML, THE TOTAL TIME WAS SET TO TEN HOURS, THE FILL VOLUME WAS SET TO 2400ML, THE LAST FILL VOLUME WAS SET TO 0ML, THE INITIAL DRAIN ALARM WAS SET TO 0ML, AND A LAST MANUAL DRAIN WAS SET TO NO. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE