BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4220026 · Received November 3, 2014

    Report

    Report Number
    1416980-2014-38383
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT NOTICED SOME AIR IN THEIR PATIENT LINE WHILE PERFORMING THERAPY ON THEIR HOMECHOICE DEVICE. THE PATIENT WAS CONNECTED TO THE HOMECHOICE AT THE TIME OF THE REPORTED EVENT. THERE WAS NOTHING UNUSUAL FOUND DURING THE TROUBLESHOOTING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703855 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR HOMECHOICE