BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2232193 · Received September 2, 2011

    Report

    Report Number
    1423500-2011-11609
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 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 HOMECHOICE (HC) DEVICE WAS RETURNED AND WAS EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL) FOR THE RITE (RETURNED INSTRUMENT TEST/EVALUATION) TESTING FAILURE FOR HEATER BAG TEMPERATURE FAILED PERFORMANCE TESTING FOR FLUID DELIVERED OUT OF SPECIFICATION. THE LAST FILL FLUID TEMPERATURE WAS 27.9- C (MIN); BELOW THE RITE LIMITS OF 35.0-C?39.0 -C. EXTERNAL/INTERNAL INSPECTION WAS PERFORMED AND PASSED. VOLUMETRIC ACCURACY TEST WAS PERFORMED AND THE DEVICE WAS FOUND TO BE FUNCTIONING WITHIN SPECIFICATION. ADDITIONAL TEMPERATURE CONFIRMATION TESTING WAS PERFORMED AND THE TEMPERATURE WAS VERIFIED TO BE WITHIN SPECIFICATION. DEVICE POWERED UP PROPERLY; PRIMING SEQUENCES WERE COMPLETED WITH NO ERRORS. CRT (CYCLER REMOTE TOOLBOX) SOFTWARE VERSION 8.800 PNEUMATIC SYSTEM INTEGRITY, CRT 8.800 TEMPMON HEATER SYSTEM INTEGRITY, AND FTC (FINAL TEST AND CALIBRATION) SOFTWARE VERSION 8.900 WERE PERFORMED FOR COMMUNICATION VERIFICATION AND THE DEVICE COMMUNICATED PROPERLY WITH ALL THREE AND NO ERRORS OCCURRED. THE COMMUNICATION RIBBON CABLE WAS INSPECTED AND IT WAS FOUND TO BE MOUNTED AND CONNECTED PROPERLY. PRODUCT ANALYSIS LAB (PAL) EVALUATED THE DEVICE AND FOUND NO FAILURE OR MALFUNCTION THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE RITE FAILURE. ASSIGNABLE CAUSE FOR THE RITE FAILURE OF HEATER BAG TEMP TEST FAILED PERFORMANCE SPEC WAS UNDETERMINED. THE DEVICE WAS SENT FOR SERVICING.

    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.

    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 TO THE DEVICE FAILED THE FLUID TEMPERATURE DELIVERY VERIFICATION STEP. 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