BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4233748 · Received November 6, 2014

    Report

    Report Number
    1416980-2014-39198
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 13, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE DEVICE RECEIVED A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDED FUNCTIONAL AND ELECTRICAL TESTING OF THE DEVICE. A VISUAL INSPECTION WAS PERFORMED. A SHORT SIMULATED THERAPY WAS SUCCESSFULLY PERFORMED. A CHECK OF THE PNEUMATIC SYSTEM FOUND THE PNEUMATIC SYSTEM WORKING TO SPECIFICATIONS. NO FAILURE OR MALFUNCTION WAS IDENTIFIED WITH THE DEVICE THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. REVIEW OF THE EVENT HISTORY DEVICE LOGS VERIFIED THE REPORTED ISSUE OF UNEXPECTED LOW UF. REVIEW OF THE DEVICE LOGS FOUND NO DRAIN VOLUME THAT MEETS THE CURRENT CRITERIA OF AN IIPV. THE CAUSE OF THE REPORTED PROBLEM WAS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT FELT THE HOME CHOICE DEVICE WAS NOT FOLLOWING THE PROGRAMMED PERITONEAL DIALYSIS THERAPY RESULTING IN AN INCREASED INTRA-PERITONEAL VOLUME (IIPV). THE HOME PATIENT STATED BOTH SOLUTION BAGS ARE EMPTY PRIOR TO THE COMPLETION OF THERAPY BUT STATES THEY CONNECT TWO FIVE-LITER SOLUTION BAGS, WHICH IS ENOUGH SOLUTION TO COMPLETE THE PROGRAMMED THERAPY. THE PATIENT¿S TOTAL FILL VOLUME EQUALED 7403ML, THE TOTAL DRAIN EQUALED 5343ML AND TOTAL ULTRAFILTRATION EQUALED -2059ML. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715096 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR