BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3213262 · Received July 9, 2013

    Report

    Report Number
    1416980-2013-17819
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 14, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING THE EVENT HISTORY LOG REVIEW, AN INCREASED INTRA-PERITONEAL VOLUME EVENT WAS IDENTIFIED. THIS IS AN ANCILLARY EVENT. THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE USE ERROR, TIDAL TOTAL ULTRA FILTRATION REMOVAL SET TOO LOW. 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. IF ANY RELEVANT INFORMATION IS OBTAINED, 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 WHICH OCCURRED DURING THE THERAPY INITIATED ON (B)(6) 2013 AT 20:51:31. DURING NIGHT DRAIN CYCLE SEVEN, THE PATIENT'S ULTRAFILTRATION READING WAS 1670ML, INDICATING THE HOME PATIENT (HP) DRAINED 1270ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2000ML. THIS INFORMATION MEETS IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314241 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR