BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2090421 · Received May 16, 2011

    Report

    Report Number
    1423500-2011-06036
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 25, 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 DEVICE HAS BEEN RECEIVED BY BAXTER, HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED ISSUE OF SPARKS FROM BACK OF THE MACHINE WAS NOT CONFIRMED IN THE DEVICE LOGS OR DUPLICATED DURING THE EVALUATION PERFORMED BY THE PAL (PRODUCT ANALYSIS LAB). THE CAUSE WAS UNDETERMINED. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED INCIDENT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED SPARKS COMING FROM THE BACK OF THE HOMECHOICE (HC) MACHINE. THE HP STATED THAT SPARKS CAME FLYING OUT OF THE HC AND NOW THE HC DOES NOT RESPOND TO ANY BUTTON PRESSES AND THE DISPLAY IS OFF. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) WILL SWAP THE DEVICE. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(6) 2011. THE NURSE WAS AWARE OF THIS EVENT AND STATED THAT THE PATIENT HAD HIS CYCLER REPLACED. THERE WAS NO FURTHER INFORMATION REGARDING THIS EVENT, HOWEVER, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    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 54 YR