BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4183086 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36427
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 14, 2014
    Report Date
    September 24, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE DEVICE WAS RETURNED AND EVALUATED. ALL RETURNED HC DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. THERE WAS NO NON-CONFORMING PRODUCT FOUND DURING SAMPLE ANALYSIS THAT WAS RELATED TO THE REPORTED ISSUE. THE EXTERNAL/INTERNAL INSPECTION WAS PERFORMED AND THE DEVICE PASSED. DURING THE DEVICE EVALUATION, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS IDENTIFIED IN THE REVIEW OF THE EVENT HISTORY LOGS. THE CAUSE WAS DETERMINED TO BE A USE ERROR, TIDAL TOTAL ULTRA FILTRATION (UF) REMOVAL SET TOO LOW. THE HOMECHOICE APD SYSTEMS TRAINER¿S GUIDE GIVES INSTRUCTIONS ON HOW TO SET THE TIDAL THERAPY SETTINGS. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2014 AT 02:15:43. DURING NIGHT DRAIN CYCLE FOUR, THE PATIENT'S ULTRAFILTRATION READING WAS 2137ML, INDICATING THE HOME PATIENT (HP) DRAINED 1917ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2200ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660472 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR