BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3212711 · Received July 9, 2013

    Report

    Report Number
    1416980-2013-17798
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    October 2, 2012
    Report Date
    June 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE DEVICE WAS EVALUATED AND THE REPORTED ISSUE WAS CONFIRMED THROUGH THE REVIEW OF THE EVENT HISTORY LOGS. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, THREE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENTS WERE IDENTIFIED WHICH OCCURRED DURING THERAPY INITIATED ON (B)(6) 2012 AT 21:01:44. DURING NIGHT DRAIN CYCLE 12, THE PATIENT'S ULTRAFILTRATION READING WAS 559ML, INDICATING THE HOME PATIENT (HP) DRAINED 559ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 800ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314060 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

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