BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOME CHOICE PRO

    MDR report key: 3200052 · Received July 1, 2013

    Report

    Report Number
    1416980-2013-16914
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    May 19, 2012
    Report Date
    June 6, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS AVAILABLE FOR EVALUATION. REVIEW OF THE EVENT LOG FOUND EVIDENCE OF THE IIPV EVENT. THE CAUSE WAS DETERMINED TO BE THAT THE USER HAD SET THE TIDAL TOTAL UF REMOVAL TOO LOW. THE HOMECHOICE APD SYSTEMS TRAINER'S GUIDE GIVES INSTRUCTIONS ON HOW TO SET THE TIDAL THERAPY SETTINGS. THIS WARNS THAT "A TOTAL UF VOLUME SET TOO LOW CAN RESULT IN A GRADUAL BUILDUP OF UF VOLUME DURING THE THERAPY. THIS CAN RESULT IN AN IIPV SITUATION." A LABELING REVIEW OF THE PRODUCT FAMILY WILL BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED. THIS OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2012, DURING NIGHT DRAIN CYCLE SIX. THE PATIENT'S ULTRAFILTRATION READING WAS 1313ML, WHICH INDICATES THAT THE HOME PATIENT (HP) DRAINED 1053ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1300ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298108 HOME CHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1