BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 4182121 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36324
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    July 1, 2014
    Report Date
    September 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED AND AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED DURING THE REVIEW OF THE EVENT HISTORY LOGS. THERE WAS NO NON-CONFORMING PRODUCT FOUND DURING SAMPLE ANALYSIS THAT WAS RELATED TO THE REPORTED ISSUE. THE CAUSE WAS DETERMINED TO BE A FALSE EMPTY DETECT AND USE ERROR, INAPPROPRIATELY BYPASSED LOW ULTRA FILTRATION (UF) ALARM. THE HOMECHOICE / HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE GIVES INSTRUCTIONS ON HOW TO BYPASS A LOW UF ALARM. A FORMAL 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 18:37:41. DURING NIGHT DRAIN CYCLE FOUR, THE PATIENT'S ULTRAFILTRATION READING WAS 1496ML, INDICATING THE HOME PATIENT (HP) DRAINED 1496ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2300ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660038 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1