BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1880629 · Received October 25, 2010

    Report

    Report Number
    1423500-2010-04855
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    October 2, 2010
    Report Date
    October 2, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION EXPECTED BUT NOT YET COMPLETED. ANY RESULTS OF EVALUATION WILL BE PROVIDED IN A FOLLOW UP EMDR.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUES OF LIGHTS DIMMING IN THE ROOM WAS NOT CONFIRMED IN THE DEVICE LOGS OR 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. THE DEVICE POWERED UP WITH NO ERRORS. ALL POWER SUPPLY AND LITHIUM VOLTAGES WERE WITHIN SPECIFICATION. THE A/C LINE CURRENT WAS MEASURED AT THE POWER ENTRY MODULE AND FOUND TO BE WITHIN SPECIFICATION. AN INSPECTION OF THE POWER SECTION FOR SIGNS OF ARCHING REVEALED NO ISSUES. NORMAL MACHINE TOTAL LINE CURRENT COULD CAUSE LIGHT DIMMING IF THE HOME PATIENT'S POWER WAS HEAVILY LOADED BY OTHER EQUIPMENT. HOWEVER, THERE IS NOT ENOUGH EVIDENCE TO MAKE A DETERMINATION. THE ASSIGNABLE CAUSE FOR THE LIGHTS DIMMING IN THE ROOM WAS UNDETERMINED. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE LIGHTS DIMMING. 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

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A HOMECHOICE (HC) WITH A BUZZING ISSUE DURING USE. THE HOME PATIENT (HP) STATED THAT THE LIGHTS WERE DIMMING IN THE ROOM ONLY WHEN THE HOMECHOICE WAS IN USE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ARRANGED TO HAVE THE DEVICE SWAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE CYCLER-REFURBISHED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1