BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    80FRN

    MDR report key: 3850869 · Received February 12, 2014

    Report

    Report Number
    9615050-2014-01151
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 14, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE ALARMED WITH A S233 (OVER-TEMPERATURE-PSC) MALFUNCTION ALARM CODE. THE PUMP WAS RETURNED TO THE BIOMEDICAL DEPT FOR AN UNSPECIFIED REASON. NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, THE DEVICE ALARMED WITH A S233 (OVER-TEMPERATURE-PSC) MALFUNCTION ALARM CODE. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93837 80FRN FRN HOSPIRA COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK