BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2950303 · Received February 8, 2013

    Report

    Report Number
    1416980-2013-03266
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    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). EVALUATION SUMMARY: THE REPORTED ISSUE OF AN IIPV EVENT WAS CONFIRMED THROUGH EVENT HISTORY LOG REVIEW. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS DURING TESTING. NO DEVICE FAILURE OR MALFUNCTION WAS IDENTIFIED DURING EVALUATION THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. THE CAUSE WAS DETERMINED TO BE USE ERROR, TIDAL TOTAL ULTRAFILTRATION (UF) REMOVAL WAS SET TOO LOW. THE LABELING INSTRUCTS THE PATIENT TO SET THEIR TARGET UF FOR TIDAL THERAPY AT 70% OF THEIR EXPECTED TOTAL UF. SETTING THE UF TARGET TOO LOW CAN CAUSE AN INCOMPLETE DRAIN WHICH CAN RESULT IN AN IIPV SITUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS BEING RETURNED TO BAXTER. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY RELEVANT ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICES (BTS) REGARDING ASSISTANCE WITH BEING STUCK DURING DRAIN 5 OF 5 ON THE HOMECHOICE MACHINE (HC). THE HOME PATIENT (HP) STATED HE HAD BEEN ON THE HC LONGER THAN 10 HOURS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO REVIEW THE DRAIN VOLUME AND FOUND THE DRAIN VOLUME TO BE 4031ML. THE TSR CONFIRMED THE HP HAD A FILL VOLUME OF 2000ML. THE TSR ALSO FOUND THE CYCLE ULTRAFILTRATION TO BE 2042ML. THIS INFORMATION MEETS INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54555 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE