BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2950755 · Received February 8, 2013

    Report

    Report Number
    1416980-2013-03339
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 9, 2013
    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
    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 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 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

    ON (B)(6) 2013, A REVIEW OF THE DEVICE EVENT HISTORY LOG WAS CONDUCTED. AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED, WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2013, AT 22:15:56H. THE DETAILS OF THE IIPV EVENT WERE AS FOLLOWS: DURING NIGHT DRAIN CYCLE SIX, THE PATIENT'S ULTRAFILTRATION READING WAS 1248ML, INDICATING THE HOME PATIENT (HP) DRAINED 1248ML 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
    54911 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1