BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 4220007 · Received November 3, 2014

    Report

    Report Number
    1416980-2014-38363
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    July 29, 2014
    Report Date
    October 7, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORTER: ZIP CODE DOCUMENTED AS (B)(6). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS COMPLETED. THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED DURING REVIEW OF THE EVENT HISTORY LOG. THE CAUSE OF THE IIPV EVENT WAS DETERMINED TO BE DUE TO ONE OR MORE CYCLES ADVANCED TO THE NEXT FILL WHEN SLOW/NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED. THIS EVENT OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2014, AT 21:36:11. DURING NIGHT DRAIN CYCLE FIVE, THE PATIENT'S ULTRAFILTRATION READING WAS 1294ML, INDICATING THE HOME PATIENT DRAINED 1294ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2100ML. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703753 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1