BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2042392 · Received April 6, 2011

    Report

    Report Number
    1423500-2011-04148
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    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 EVALUATION OF THE DEVICE HAS BEGUN; HOWEVER, HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE 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 DEVICE FAILED THE HOMECHOICE RITE FUNCTIONAL TEST AND PASSED HOMECHOICE RITE ELECTRICAL TEST. HOWEVER THE DEVICE WAS DETERMINED TO MEET THE SPECIFICATION REQUIREMENTS RELATIVE TO THE INCREASED INTRA-PERITONEAL VOLUME (IIPV). THE CAUSE OF THE IIPV IDENTIFIED IN THE DEVICE LOG WAS DETERMINED TO BE INSUFFICIENT DRAIN- MINIMUM DRAIN VOLUME PERCENTAGE SETTING TOO LOW. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. 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, AN ADDITIONAL ISSUE OF AN INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENT WAS FOUND IN THE THERAPY LOGS:(B)(6) 2011 AT 07:31:51 WITH DRAIN VOLUME OF 3418 ML (MILLILITERS) DURING CYCLE 4. ON (B)(6) 2011, PRODUCT SURVEILLANCE SPOKE WITH THE HOME PATIENT'S (HP) NURSE. RESULTS OF EVALUATION WERE PROVIDED. THE NURSE COMMENTED THIS PATIENT IS AN ENGINEER. THE NURSE STATED SHE WAS IN A MEETING AND HAD NO FURTHER DETAIL TO PROVIDE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR