BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 4243540 · Received November 11, 2014

    Report

    Report Number
    1416980-2014-39906
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR ANALYSIS AND AN EVALUATION HAS BEGUN BUT HAS NOT YET BEEN COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER HEALTHCARE FOR FURTHER INVESTIGATION. THE HOMECHOICE DEVICE RECEIVED A RETURNED INSTRUMENT TESTING EVALUATION (RITE). AN EXTERNAL/INTERNAL INSPECTION WAS PERFORMED ON THE DEVICE AND FOUND NO ISSUES. THE DEVICE PASSED RITE ELECTRICAL AND FUNCTIONAL TESTING. THE PNEUMATIC SYSTEM OF THE DEVICE WAS TESTED AND FOUND TO BE WORKING TO SPECIFICATIONS. A SHORT SIMULATED THERAPY WAS SUCCESSFULLY COMPLETED ON THE DEVICE. THE REPORTED IIPV EVENT WAS IDENTIFIED IN THE EVENT HISTORY LOG, BUT DURING SAMPLE EVALUATION NO NONCONFORMING PRODUCT WAS FOUND RELATED TO THE REPORTED ISSUE. THE DEVICE WAS DETERMINED TO MEET SPECIFICATIONS. THE SERVICE HISTORY REVIEW FOUND THAT THE PREVIOUS DEVICE SERVICING DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE. THE CAUSE OF THE HIGH DRAIN ALARM WAS DETERMINED TO BE ONE OR MORE CYCLES ADVANCING TO THE NEXT FILL WHEN A SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT RECEIVED A HIGH DRAIN 104 ALARM ON THE HOME CHOICE DEVICE, AFTER THERAPY WAS COMPLETED. A HIGH DRAIN ALARM INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME. THE TOTAL DRAIN VOLUME EQUALED 15061ML AND THE TOTAL ULTRAFILTRATION (UF) EQUALED 4082ML. THE ULTRAFILTRATION FOR CYCLE FOUR WAS 4327ML.THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND ARRANGED TO SWAP THE DEVICE. THE TSR DISCUSEED THE USE OF MANUAL SUPPLIES UNTIL THE NEW DEVICE ARRIVED. 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
    727684 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR