BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3802331 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-14909
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    May 25, 2013
    Report Date
    April 15, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. REVIEW OF THE EVENT LOG FOUND EVIDENCE OF THE REPORTED IIPV CONDITION. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT. THE CAUSE WAS USE ERROR, TIDAL TOTAL UF REMOVAL SET TOO LOW. 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 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 WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2013 21:17:28. DURING NIGHT DRAIN CYCLE FIVE, THE PATIENT'S ULTRAFILTRATION READING WAS 1379ML, INDICATING THE HOME PATIENT (HP) DRAINED 1294ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1700ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280789 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1