BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3243306 · Received July 23, 2013

    Report

    Report Number
    1416980-2013-19484
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. THE DEVICE PASSED FUNCTIONAL AND ELECTRICAL TESTING. ALL PRESSURES WERE FOUND TO BE CORRECT AND STABLE. A SHORT SIMULATED THERAPY WAS PERFORMED AND COMPLETED SUCCESSFULLY. NO PROBLEMS WERE FOUND DURING AN INTERNAL INSPECTION OF THE DEVICE. THE REPORTED ISSUE WAS CONFIRMED IN THE DEVICE LOGS. THE CAUSE WAS DETERMINED TO BE ONE OR MORE CYCLES WERE ADVANCED 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 (HP) HAD A HIGH DRAIN 104 ALARM ON THE HOMECHOICE (HC) DURING FILL CYCLE OF THE THERAPY, WHILE THE HP WAS CONNECTED. THE HIGH DRAIN ALARM INDICATES THAT THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME IN STANDARD MODE, MEETING INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA. THE HP?S FILL VOLUME WAS 2000 ML. THE HP DID NOT BYPASS AND DID A MID-DRAIN. 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
    342957 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE