BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2860628 · Received December 6, 2012

    Report

    Report Number
    1416980-2012-06624
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    October 14, 2011
    Report Date
    November 12, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Removal / Correction Number
    1423500-01/08/10-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A HOMECHOICE UNIT (SERIAL NUMBER: (B)(4)) WAS RETURNED TO BAXTER FOR A SOFTWARE UPGRADE, DUE TO A FIELD CORRECTIVE ACTION (2009FCA07) INITIATED (B)(6) 2011 BY BAXTER (B)(4). IN ADDITION TO THE SOFTWARE UPGRADE, AN EVALUATION OF THE DEVICE EVENT HISTORY LOG WAS CONDUCTED ON (B)(6) 2012. AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED, WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2011 AT 22:49:41H. AT THIS TIME BAXTER WAS NOT CONTACTED BY THE PATIENT FOR ASSISTANCE. THE DETAILS OF THE IIPV EVENT WERE AS FOLLOWS; DURING NIGHT DRAIN CYCLE SEVEN, THE PATIENT'S ULTRAFILTRATION READING WAS 1604ML, INDICATING THE HOME PATIENT (HP) DRAINED 1604ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2000ML. THIS INFORMATION MEETS IIPV CRITERIA, AND IS A REPORTABLE MALFUNCTION. IT IS UNKNOWN HOW LONG THE DEVICE WAS IN USE WHEN THE EVENT OCCURRED. FURTHERMORE, AS THIS EVENT WAS FOUND DURING SERVICE, ANY PATIENT INJURY OR MEDICAL INTERVENTION IS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1