BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3770786 · Received April 24, 2014

    Report

    Report Number
    1416980-2014-13207
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    December 4, 2013
    Report Date
    April 1, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS EVALUATED AND THE ISSUE WAS CONFIRMED THROUGH THE REVIEW OF THE EVENT HISTORY LOGS. THE CAUSE WAS UNABLE TO BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A HIGH DRAIN ALARM 103 (INDICATING THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME, MEETING INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA) WAS IDENTIFIED IN THE LOG. THE ALARM OCCURRED ON (B)(6) 2013 AT 13:00:00. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248789 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR