BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2230875 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11546
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    July 14, 2011
    Report Date
    August 8, 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 WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) FOUND IN THE DEVICE LOGS. THE ASSIGNABLE CAUSE OF THE IIPV IDENTIFIED VIA DEVICE LOG REVIEW WAS DETERMINED TO BE INSUFFICIENT DRAIN, USE ERROR, TIDAL UF REMOVAL SET TOO LOW. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. NO ISSUES WERE IDENTIFIED DURING THE REVIEW OF THE ACTUAL DEVICE?S PREVIOUS SERVICE HISTORY RECORD (SHR) THAT MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY OR THE ADDITIONAL IIPV. THE DEVICE WAS DETERMINED TO MEET SPECIFICATIONS FOR THE IIPV FOUND IN THE LOGS. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE HAS BEEN ESCALATED TO CAPA.

    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.

    Description of Event or Problem · 1

    DURING INITIAL ASSESSMENT OF A RETURNED HOMECHOICE MACHINE, A BAXTER TECHNICIAN FOUND AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT THAT WAS IDENTIFIED IN THE PATIENT THERAPY LOG ON (B)(6) 2011 AT 04:52:31 WITH DRAIN VOLUME OF 3121 ML DURING CYCLE 6. THE FILL VOLUME IS 1800 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 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1