BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2902095 · Received January 8, 2013

    Report

    Report Number
    1416980-2013-00518
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    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 HAS NOT YET BEEN RECEIVED BUT AN EVALUATION IS EXPECTED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION WAS CONFIRMED IN THE EVENT HISTORY LOG REVIEW. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS DURING EVALUATION. THE CAUSE WAS DETERMINED TO BE A USE ERROR, AS THE TIDAL TOTAL UF REMOVAL SET TOO LOW.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICES (BTS) REGARDING ASSISTANCE WITH A HIGH DRAIN 104 ALARM DURING DRAIN 4 OF 4 ON THE HOMECHOICE MACHINE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) TO PRESS STOP AND GO. THE HC WENT TO WEIGHT. THE TSR ASSISTED THE HP TO PRESS STOP TO CHECK THE PROGRAMMING. THE THERAPY WAS SET FOR TIDAL WITH A FILL VOLUME OF 2000ML, TIDAL VOLUME OF 95%, TOTAL ULTRAFILTRATION OF 150ML, LAST FILL VOLUME OF 1000ML, DEXTROSE SET TO SAME, AND WEIGHT UNIT = KG. THE TSR ASSISTED THE HP TO CHECK THE THERAPY LOG. THERAPY COMPLETED WITH A LAST FILL VOLUME OF 999ML, TOTAL FILL OF 7696ML, TOTAL DRAIN OF 9882ML, TOTAL ULTRAFILTRATION(UF) OF 2185ML, AND CYCLE 4 UF OF 2174ML. THE TSR EXPLAINED THE ALARM AND POSSIBLE CAUSE. THE TSR CONFIRMED THE HP DID NOT USE ANY DIFFERENT DEXTROSE ON THE HC LAST NIGHT. THE HP STATED HE USED HIS NORMAL RED AND GREEN BAGS, BUT THE OTHER NIGHT HE USED 2 GREEN BAGS AND WOKE UP EXTRA PUFFY. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8549 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE