BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2090202 · Received May 16, 2011

    Report

    Report Number
    1423500-2011-05993
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 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 AT BAXTER FOR EVALUATION. HOWEVER, THE EVALUATION IS NOT COMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) DEVICE WAS RECEIVED FOR EVALUATION AT THE PRODUCT ANALYSIS LAB (PAL). THE HC RETURNED INSTRUMENT TEST EVALUATION (RITE) ELECTRICAL TEST FAILED DUE TO FAILURE OF THE GROUND BOND PERFORMANCE SPECIFICATION. THE RITE ELECTRICAL TEST WAS CONFIRMED DUE TO THE FAILURE. CONTINUITY WAS MEASURED BETWEEN POWER ENTRY MODULE AND DOORPOST; GROUND BUS RESISTANCE MEASURED WOULD NOT STABILIZE, INDICATING AN ISSUE WITH GROUND BUS IN THE DEVICE. CONTINUITY TO ALL OTHER INTERNAL GROUNDS FROM POWER ENTRY MODULE AND DOOR FRAME WAS WITHIN SPECIFICATION. THE CAUSE OF THE RITE ELECTRICAL TEST FAILURE OF GROUND BOND FAILED PERFORMANCE SPECIFICATION WAS DETERMINED TO BE A POOR CONNECTION BETWEEN THE DOOR POST AND DOOR FRAME. A SERVICE HISTORY REVIEW (SHR) REVEALED THAT NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE ISSUE OF FAILED GROUND BOND TEST. 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. THE DOOR POST WOULD BE SCRAPPED DURING SERVICING.

    Description of Event or Problem · 1

    A BAXTER SERVICE TECHNICIAN FOUND THAT A HOMECHOICE SYSTEM FAILED A GROUND BOND PERFORMANCE SPECIFICATION TEST.

    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