BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3840464 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17362
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 6, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS UNDERWAY. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND A VISUAL INSPECTION, FUNCTIONAL TESTING, ELECTRICAL TESTING AND CALIBRATION WAS PERFORMED WITH NO ISSUES. IN ADDITION A PRESSURE LEAK TEST AND SIMULATED THERAPY WAS PERFORMED WITH NO PROBLEMS. THE EVENT HISTORY LOG REVIEW INDICATED SEVERAL ALARMS. DURING SAMPLE EVALUATION THE REPORTED CONDITION WAS VERIFIED AS A SYSTEM ERROR 2392. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE DUE TO THE DIGITAL BOARD. TO CORRECT THE CONDITION THE DIGITAL BOARD WAS REPLACED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A NURSE REPORTED AN UNSPECIFIED FAILURE THAT OCCURRED ON THE HOMECHOICE DEVICE OUTSIDE OF PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318209 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1