BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2031942 · Received March 28, 2011

    Report

    Report Number
    1423500-2011-03751
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 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 RITE ELECTRICAL TEST FAILURE GROUND BOND FAILED PERFORMANCE SPECIFICATION WAS NOT CONFIRMED BY REVIEW OF THE LOGS OR DUPLICATED DURING PAL EVALUATION. INTERNAL/EXTERNAL INSPECTION PER (B)(4) FOUND NO ISSUES. PAL METHOD 3 EVALUATION FOUND NO ISSUES WITH GROUND BOND IN THE DEVICE, CONTINUITY WAS MEASURED BETWEEN POWER ENTRY MODULE AND DOORPOST; GROUND BUS RESISTANCE MEASURED 12M' (.012') INDICATING NO ISSUE WITH GROUND BUS IN THE DEVICE. THE CAUSE OF THE RITE ELECTRICAL TEST FAILURE OF GROUND BOND FAILED PERFORMANCE SPECIFICATION WAS UNDETERMINED. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    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.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, THE PRODUCT ANALYSIS LABORATORY DETERMINED THE HC MACHINE SYSTEM FAILED RETURNED INSTRUMENT TEST/EVALUATION TESTING DUE THE DEVICE FAILED THE GROUND BOND TEST INDICATING A HIGH RESISTANCE VALUE BETWEEN THE HC AND THE GROUND BOND ON THE POWER SUPPLY.

    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