BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1880241 · Received October 22, 2010

    Report

    Report Number
    1423500-2010-04800
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 4, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE HAD REVERTED TO THE FACTORY DEFAULT PROGRAM SETTINGS ON 2 OCCASIONS. THE REPORTED DIFFICULTY OF THE DEVICE REVERTING TO THE FACTORY DEFAULT PROGRAM SETTINGS WAS NEITHER CONFIRMED IN THE DEVICE LOGS NOR DUPLICATED DURING EVALUATION. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. THE PRODUCT ANALYSIS LAB (PAL) EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. THE DEVICE FUNCTIONED NORMALLY DURING PAL TESTING. THE ASSIGNABLE CAUSE OF THE DEVICE REVERTING TO THE FACTORY DEFAULT PROGRAM SETTINGS WAS UNDETERMINED. THE PREVIOUS RETURN OF THE DEVICE WAS NOT FOR ANY ISSUES RELATED TO PROGRAM CHANGED BY DEVICE. 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). DEVICE EVALUATION EXPECTED BUT NOT YET COMPLETED. ANY ADDITIONAL INFORMATION OR RESULTS OF EVALUATION WILL BE PROVIDED IN A FOLLOW UP EMDR.

    Description of Event or Problem · 1

    THE HOME PATINET STATED THAT ON TWO DIFFERENT OCCASIONS THE HOME CHOICE (HC) HAD THE THERAPY GO TO THE FACTORY DEFAULT SETTINGS. THE TECHNICAL SERVICE RESPRESENTATIVE (TSR) WOULD SWAP THE HC. THERE WAS 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 CYCLER-REFURBISHED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1