BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 4802118 · Received May 28, 2015

    Report

    Report Number
    1416980-2015-23137
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    December 25, 2014
    Report Date
    May 5, 2015
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND THE EVALUATION IS COMPLETE. A REVIEW OF THE EVENT HISTORY LOG VERIFIED THE OCCURRENCE OF AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE OF THE IIPV COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT ADDITIONAL 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 104 (NIGHT DRAIN #4) 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) 2014 AT 11:13:00. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345395 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1