BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2070060 · Received April 26, 2011

    Report

    Report Number
    1423500-2011-05063
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    April 9, 2011
    Report Date
    April 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE OF THERAPY WAS RESET WAS CONFIRMED IN THE DEVICE LOGS BUT NOT DUPLICATED DURING THE EVALUATION PERFORMED BY THE PAL (PRODUCT ANALYSIS LAB). THE DEVICE WAS RECEIVED OPERATIONAL AND IN GOOD CONDITION. THE DEVICE PASSED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST / EVALUATION), FUNCTIONAL AND ELECTRICAL TESTS AND WAS FUNCTIONING WITHIN SPECIFICATION. A REVIEW OF THE DEVICE LOGS REVEALED THE DATA HAD BEEN ERASED, CONFIRMING THE REPORTED ISSUE, WHICH IS INDICATIVE OF A DIGITAL PRINTED CIRCUIT BOARD (PCB) MALFUNCTION. THE ASSIGNABLE CAUSE FOR THERAPY WAS RESET WAS DETERMINED TO BE AN INTERMITTENT DIGITAL PCB. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE THERAPY BEING RESET. 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). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S (B)(4) TO REPORT A THERAPY WAS RESET MESSAGE ON A HOMECHOICE (HC) MACHINE DURING SET UP, PATIENT NOT CONNECTED. THE HOME PATIENT (HP) STATED THAT SHE WAS STARTING OVER WITH NEW SUPPLIES AND WHEN SHE TURNED THE HC BACK ON, THE DISPLAY READ THERAPY WAS RESET. THE TOTAL VOLUME (TV) WAS 200 MILLILITERS (ML). THE HP JUST GOT THIS HC TODAY, FIRST CLINICAL USE OF THIS DEVICE - OUT OF BOX FAILURE, SWAP WITHIN THE LAST FIVE DAYS, BUT THE REGISTERED NURSE (RN) IS AWARE OF ORIGINAL SWAP. THE HP WILL USE MANUAL SUPPLIES. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO CALL THE RN. THE TSR DISCUSSED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) UNTIL THE NEW MACHINE ARRIVES. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 58 YR