BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2073272 · Received May 1, 2011

    Report

    Report Number
    1423500-2011-05228
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 6, 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 RECEIVED AND EVALUATED. THE DEVICE WAS DETERMINED TO MEET SPECIFICATIONS RELATIVE TO THE IIPV IDENTIFIED DURING DEVICE LOGS REVIEW. NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE DEVICE'S PREVIOUS SERVICE HISTORY RECORD (SHR) THAT MAY HAVE CONTRIBUTED TO THE IIPV. THE ASSIGNABLE CAUSE FOR THE IIPV FOUND IN THE LOGS WAS ALSO UNDETERMINED. 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 (B)(4).

    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 EVALUATION, AN ADDITIONAL ISSUE OF AN INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENT WAS FOUND IN THE PATIENT EVENT LOGS: OCCURRENCE DATE (B)(6) 2011 WITH ULTRAFILTRATION (UF) VOLUME OF 1236 MILLILITERS (ML) DURING CYCLE 4. THE FILL VOLUME WAS 2000ML. 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