BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2022715 · Received March 17, 2011

    Report

    Report Number
    1423500-2011-03344
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 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, AND THE EVALUATION IS IN PROCESS. 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 HOMECHOICE (HC) DEVICE WAS RECEIVED OPERATIONAL AND IN GOOD CONDITION FOR EVALUATION AT THE PRODUCT ANALYSIS LAB (PAL). THE DEVICE PASSED THE HC RETURN INSTRUMENT TEST / EVALUATION (RITE) FUNCTIONAL TEST BUT FAILED THE RITE ELECTRICAL TEST FOR GROUND BOND FAILED PERFORMANCE SPECIFICATION. THE MAIN GROUND BUS RESISTANCE WAS CHECKED BETWEEN THE DOOR POST AND THE POWER ENTRY MODULE. THE READING WAS WITHIN GROUND BOND SPECIFICATION; HOWEVER, A LOOSE CONNECTION WAS DETECTED WHILE AGITATING THE GROUND WIRE AT THE DOOR POST. THE CAUSE OF GROUND BOND FAILED WAS DETERMINED TO BE LOOSE CONNECTION AT DOOR GROUND POST AND POWER ENTRY MODULE GROUND LEAD. A SERVICE HISTORY REVIEW (SHR) REVEALED THAT NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO 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.

    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. THERE WAS NO PATIENT INVOLVEMENT.

    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