BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2132974 · Received June 17, 2011

    Report

    Report Number
    1423500-2011-07793
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    December 30, 2010
    Report Date
    June 10, 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
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE DEVICE REPORTED HAS BEEN RECEIVED BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS INSUFFICIENT DRAIN - TIDAL ULTRAFILTRATION REMOVAL SET TOO LOW. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THE DEVICE PASSED ALL REQUIRED TESTS AND CALIBRATIONS PRIOR TO ITS RELEASE. NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION. RENAL QUALITY ENGINEERING, ALONG WITH PLANT SERVICING AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR PRODUCT LINES FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    A SINGLE EVENT OF INCREASED INTRAPERITONEAL VOLUME (IIPV) WAS IDENTIFIED IN THE PATIENT EVENT LOG DURING THE INITIAL DEVICE EVALUATION WHICH OCCURRED ON (B)(6) 2010 AT 10:44:10 WITH A DRAIN VOLUME (DV) OF 3577ML DURING CYCLE 4.

    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 39 YR LOWCAL (PD4) AMBUFLEX| LOWCAL (PD4) ULTRABAG