BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4973317 · Received August 5, 2015

    Report

    Report Number
    1416980-2015-31535
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    April 20, 2015
    Report Date
    July 14, 2015
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND THE EVALUATION IS COMPLETE. DURING THE EVENT HISTORY LOG REVIEW, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE OF THE IIPV 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 DEVICE, A HIGH DRAIN 111 (NIGHT DRAIN #11) ALARM WAS IDENTIFIED IN THE LOG. THIS ALARM INDICATES THAT THE PATIENT DRAINED GREATER THAN OR EQUAL TO 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME. THE ALARM OCCURRED ON (B)(6) 2015 AT 10:40:13. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514023 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1