BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2120567 · Received June 10, 2011

    Report

    Report Number
    1423500-2011-07445
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    April 5, 2011
    Report Date
    May 23, 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 HOMECHOICE (HC) DEVICE WAS RECEIVED FOR EVALUATION AT THE PRODUCT ANALYSIS LAB (PAL). A REVIEW OF THE DEVICE LOGS CONFIRMED THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT. THE CAUSE OF THE IIPV FOUND IN THE LOGS WAS DETERMINED TO BE INSUFFICIENT DRAIN DUE TO ONE OR MORE CYCLE ADVANCING TO THE NEXT FILL WHEN SLOW/NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. THE DEVICE MET SPECIFICATIONS RELATIVE TO THE IIPV FOUND IN THE LOGS. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RTB-CAPA-(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 STARTED AT 21:11 WITH UF VOLUME OF 991 ML DURING CYCLE 8. THE FILL VOLUME WAS 1500ML. 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