BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 5221081 · Received November 12, 2015

    Report

    Report Number
    1416980-2015-41737
    Event Type
    Malfunction
    Date Received
    November 12, 2015
    Date of Event
    July 26, 2015
    Report Date
    November 12, 2015
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND THE EVALUATION IS COMPLETE. DURING THE EVENT HISTORY LOG REVIEW, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THIS EVENT. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE OF THIS ISSUE WAS DETERMINED TO BE USE ERROR, TIDAL TOTAL ULTRAFILTRATION REMOVAL SET TOO LOW. THE HOMECHOICE APD SYSTEMS TRAINER¿S GUIDE GIVES INSTRUCTIONS ON HOW TO SET THE TIDAL THERAPY SETTINGS. A 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. THIS EVENT OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2015 AT 20:51:49. DURING NIGHT DRAIN CYCLE FIVE, THE PATIENT'S ULTRAFILTRATION READING WAS 1684ML, INDICATING THE HOME PATIENT DRAINED 1399ML 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
    750989 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1