BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3851930 · Received June 5, 2014

    Report

    Report Number
    1416980-2014-18042
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION IS COMPLETE. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT. THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED IN THE EVENT HISTORY LOG REVIEW. AN INTERNAL AND EXTERNAL VISUAL INSPECTION WAS PERFORMED. ALL RETURNED HOMECHOICE DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. THE CAUSE OF THE IIPV EVENT WAS DETERMINED TO BE A USE ERROR, FURTHER SPECIFIED AS THE TOTAL TIDAL ULTRA FILTRATION (UF) REMOVAL WAS SET TOO LOW. THE HOMECHOICE APD SYSTEMS TRAINER¿S GUIDE GIVES INSTRUCTIONS ON HOW TO SET THE TIDAL THERAPY SETTINGS. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP 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 WHICH OCCURRED DURING THERAPY INITIATED ON (B)(6) 2014 AT 21:46:38. DURING NIGHT DRAIN CYCLE EIGHT, THE PATIENT'S ULTRAFILTRATION READING WAS 1440ML, INDICATING THE HOME PATIENT (HP) DRAINED 1250ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1900ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329190 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR