BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2120564 · Received June 10, 2011

    Report

    Report Number
    1423500-2011-07443
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    April 22, 2011
    Report Date
    May 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HC DEVICE WAS RECEIVED FOR EVALUATION AT THE PRODUCT ANALYSIS LAB (PAL). A REVIEW OF THE DEVICE LOGS CONFIRMED THE IIPV EVENT, BUT COULD NOT DUPLICATE DURING THE PAL EVALUATION. THE CAUSE OF THE IIPV FOUND IN THE LOGS WAS DETERMINED TO BE INSUFFICIENT DRAIN DUE TO USE ERROR; THE TIDAL ULTRAFILTRATE (UF) REMOVAL WAS SET TOO LOW. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE SUFFICIENT. A SERVICE HISTORY REVIEW (SHR) REVEALED THAT NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE IIPV. DEVICE MET SPECIFICATIONS RELATIVE TO IIPV ENCOUNTERED IN THE LOGS. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH (B)(4).

    Description of Event or Problem · 1

    DURING INITIAL ASSESSMENT OF A RETURNED HOMECHOICE MACHINE, A BAXTER TECHNICIAN FOUND AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) THAT WAS IDENTIFIED IN PATIENT THERAPY LOG ON (B)(6) 2011 AT 00:44 WITH ULTRAFILTRATION OF 1337 ML DURING CYCLE 3. THE FILL VOLUME WAS 2000 ML. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED. THIS EVENT MEETS OVERFILL CRITERIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1