BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4033373 · Received August 25, 2014

    Report

    Report Number
    1416980-2014-27900
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    May 23, 2014
    Report Date
    July 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RECEIVED AND THE EVALUATION IS COMPLETE. THIS IS AN ANCILLARY SERVICE EVENT. THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED THROUGH AN EVENT HISTORY LOG REVIEW. AN INTERNAL AND EXTERNAL VISUAL INSPECTION WAS PERFORMED. FULL FUNCTIONAL TESTING, ELECTRICAL SAFETY TESTING , CALIBRATION AND SIMULATED THERAPY WAS PERFORMED WITH NO OTHER DEFECTS AND MALFUNCTIONS FOUND WITH THE DEVICE. THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE USE ERROR, TIDAL TOTAL ULTRAFILTRATION REMOVAL SET TOO LOW. HOMECHOICE APD SYSTEMS TRAINER¿S GUIDE GIVES INSTRUCTIONS ON HOW TO SET THE TIDAL THERAPY SETTINGS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT 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. THIS EVENT OCCURRED DURING THE THERAPY INITIATED ON (B)(6) 2014 AT 23:36:12. DURING NIGHT DRAIN CYCLE EIGHT, THE PATIENT'S ULTRAFILTRATION READING WAS 2046ML, INDICATING THE HOME PATIENT DRAINED 1146ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1800ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512395 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1