BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3023503 · Received March 27, 2013

    Report

    Report Number
    1416980-2013-07435
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER, THEREFORE, NO EVALUATION COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENT OCCURRED WITH A HOMECHOICE MACHINE DURING PERITONEAL DIALYSIS (PD) THERAPY, AFTER USE. THE HOME PATIENT (HP) STATED, THE MACHINE ALARMED HIGH DRAIN 106 AT THE END OF THERAPY. THE HP STATED THEIR DRAIN VOLUME (DV) WAS 4100ML AND NORMALLY IS 3500ML-3900ML FOR A 2000ML FILL VOLUME (FV). THE HP STATED THEY FELT FINE. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) EXPLAINED THAT THE ALARM IS TRIGGERED BY A DRAIN VOLUME THAT IS TWICE AS HIGH AS THE FILL VOLUME. THE HP IS ON TIDAL THERAPY AND THE TOTAL UF IS PROGRAMMED AT 100ML. THE HP STATED HIS TOTAL ULTRAFILTRATION (UF) AT THE END OF THE TREATMENT IS NORMALLY AROUND 1600ML TO 1800ML. THE TSR EXPLAINED THAT THE PROGRAMMING NEEDS TO ACCOUNT FOR THAT AND ADVISED THE HP TO CALL HIS NURSE TO REVIEW THE TOTAL UF IN THE PROGRAMMING. THERE WAS PATIENT INVOLVEMENT, BUT NO CLINICAL CONSEQUENCES FOR THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126411 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1