BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4221177 · Received November 3, 2014

    Report

    Report Number
    1416980-2014-38552
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    June 15, 2014
    Report Date
    October 9, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE DEVICE WAS RETURNED AND EVALUATED. THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED DURING THE REVIEW OF THE EVENT HISTORY LOG; HOWEVER, THE CAUSE COULD NOT BE DETERMINED. THERE WAS NO NON-CONFORMING PRODUCT FOUND DURING SAMPLE ANALYSIS THAT WAS RELATED TO THE REPORTED ISSUE. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A HIGH DRAIN ERROR 101 (NIGHT DRAIN 1) ALARM WAS IDENTIFIED IN THE LOG. A HIGH DRAIN ALARM OCCURS WHEN A PATIENT HAS DRAINED A VOLUME EQUAL TO 200% OR GREATER THAN THE PATIENT¿S PRESCRIBED FILL VOLUME. THE ALARM OCCURRED ON (B)(6) 2014 09:59:21. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702698 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1