BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3160795 · Received June 11, 2013

    Report

    Report Number
    1416980-2013-14910
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED AT THIS TIME. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY REVIEW WAS PERFORMED FINDING NO EXCEPTION, NONCONFORMANCE, OR REWORK THAT OCCURRED DURING THE MANUFACTURING OF THE DEVICE WITH THIS SERIAL NUMBER. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS THAT WERE RELATED TO THE REPORTED CONDITION. DURING EVALUATION OF THE DEVICE SIMULATED THERAPY WAS PERFORMED AND COMPLETED WITH NO ISSUES NOTED. THE REPORTED ISSUE COULD NOT BE CONFIRMED IN THE LOG REVIEW NOR DUPLICATED DURING TESTING OF THE DEVICE. DURING VISUAL INSPECTION OF THE DEVICE, NO ISSUES WERE FOUND. THE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. THE DEVICE WAS SENT FOR NORMAL SERVICING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOMECHOICE (HC) MACHINE DID NOT DISPLAY THE CORRECT FILL AND DRAIN VOLUMES. THE HOME PATIENT'S (HP) PRESCRIPTION WAS FOR APPROXIMATELY 16 L WHILE THE VOLUMES RECORDED ON THE MACHINE AT THE END OF THERAPY WERE 14 L FILLED AND 15 L DRAINED. AT THE END OF THE THERAPY, ALL OF THE BAGS WERE EMPTY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263207 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN PD SOLUTION| 5L AND 2L BAGS