BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3223724 · Received July 12, 2013

    Report

    Report Number
    1416980-2013-18199
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    July 20, 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 RETURNED TO BAXTER AND THE EVALUATION WAS COMPLETED. THIS EVENT REPRESENTS AN ANCILLARY SERVICE EVENT. THE IIPV EVENT WAS CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. HOWEVER, THE CAUSE OF THIS EVENT WAS NOT DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL 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. THIS OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2012, DURING NIGHT DRAIN CYCLE EIGHT. THE PATIENT'S ULTRAFILTRATION READING WAS 1134ML, INDICATING THE HOME PATIENT (HP) DRAINED 1134ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1200ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323082 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1