BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2061135 · Received April 18, 2011

    Report

    Report Number
    1423500-2011-04633
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 9, 2011
    Report Date
    April 13, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    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 RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB. THE HOMECHOICE PASSED THE RITE ELECTRICAL TEST AND FAILED THE RITE FUNCTIONAL TEST FOR A DISPLAY ISSUE. THE ASSIGNABLE CAUSE WAS THE DIGITAL PRINTED CIRCUIT BOARD (PCB) ASSEMBLY, WHICH WAS SCRAPPED. THE CAUSE OF THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) IDENTIFIED IN THE DEVICE LOG WAS DETERMINED TO BE INSUFFICIENT DRAIN - TIDAL ULTRAFILTRATION REMOVAL SET TOO LOW. A LABEL REVIEW WAS PERFORMED AND FOUND TO BE ADEQUATE FOR THE USE ERROR IDENTIFIED IN THIS REPORT. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION OF IIPV. 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)).

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION WAS IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE DEVICE, WHICH OCCURRED DURING DRAIN CYCLE 5. THE PROGRAMMED FILL VOLUME WAS 2100 ML AND ULTRAFILTRATION WAS 1783 ML. THIS MEETS BAXTER'S IIPV CRITERIA. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 36 YR