BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2934583 · Received January 30, 2013

    Report

    Report Number
    1416980-2013-02249
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    December 2, 2012
    Report Date
    January 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE DEVICE WAS RETURNED TO BAXTER, AND THE EVALUATION IS COMPLETE. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE REPORTED DIFFICULTY OF AN IIPV EVENT WAS CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS ONE OR MORE CYCLE ADVANCES TO NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2012 22:10:04. DURING NIGHT DRAIN CYCLE FOUR, THE PATIENT'S ULTRAFILTRATION READING WAS 141ML, INDICATING THE HOME PATIENT (HP) DRAINED 141ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 200ML. THIS INFORMATION MEETS IIPV CRITERIA. UPON FURTHER INVESTIGATION, THE UF READING FROM DRAIN CYCLE FIVE WAS ADDED INTO THE UF READING FOR DRAIN CYCLE FOUR DUE TO THE PATIENT ENDING THERAPY BEFORE THE DRAIN WAS COMPLETED. THE DRAIN VOLUME OF DRAIN CYCLE FOUR WAS 199 ML, WHICH DOES NOT MEET IIPV CRITERIA. HOWEVER, THE DRAIN VOLUME FOR DRAIN CYCLE FIVE WAS FOUND TO BE 339 ML, WHICH DOES MEET IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40658 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1