BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2103406 · Received May 26, 2011

    Report

    Report Number
    1423500-2011-06532
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 11, 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 BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. 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 DEVICE WAS RECEIVED AND EVALUATED. ADDITIONAL ISSUE OF IIPV WAS CONFIRMED IN THE THERAPY LOG, BUT NOT DUPLICATED DURING PAL EVALUATION. THE ASSIGNABLE CAUSE WAS: INSUFFICIENT DRAIN. USE ERROR. TIDAL UF REMOVAL SET TOO LOW. A REVIEW OF THE PREVIOUS SERVICE RECORD, (B)(6) 2009, SHOWS THE DEVICE PASSED ALL REQUIRED TESTS AND CALIBRATIONS PRIOR TO ITS RELEASE FROM THE TAMPA BAY FACILITY. NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE ISSUE OF IIPV. THE PREVIOUS RETURN OF THE DEVICE WAS NOT FOR ANY ISSUE RELATED TO. DEVICE MET SPECIFICATIONS RELATIVE TO THE IIPV. 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.

    Description of Event or Problem · 1

    DURING EVALUATION, AN ISSUE OF AN INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENT WAS FOUND IN THE PATIENT EVENT LOGS: OCCURRENCE DATE (B)(4) 2011 WITH ULTRAFILTRATION (UF) VOLUME OF 1470 MILLILITERS (ML) DURING CYCLE 7. THIS DRAIN VOLUME MEETS BAXTER'S IIPV CRITERIA. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 62 YR HOME CHOICE CASSETTE