BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3212825 · Received July 9, 2013

    Report

    Report Number
    1416980-2013-17802
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED AND THE REPORTED ISSUE WAS CONFIRMED THROUGH THE REVIEW OF THE EVENT HISTORY LOGS. THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE INSUFFICIENT DRAIN DUE TO ONE OR MORE CYCLES ADVANCING TO THE NEXT FILL WHEN SLOW OR NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED DURING THERAPY INITIATED ON (B)(6) 2013 01:02:50. DURING NIGHT DRAIN CYCLE THREE, THE PATIENT'S ULTRAFILTRATION READING WAS 1218ML, INDICATING THE HOME PATIENT (HP) DRAINED 1218ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1900ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313251 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE