BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-F 4000 PLUS

    MDR report key: 1944165 · Received December 6, 2010

    Report

    Report Number
    2921482-2010-00951
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 7, 2010
    Report Date
    November 9, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K882594
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT LINE D OF THE DEVICE CONTINUED TO DELIVER AFTER THE STOP KEY WAS PRESSED. THE PUMP WAS RETURNED TO THE BIOMEDICAL DEPT WITH AN UNSIGNED NOTE THAT STATED, "NUMBER KEYS DO NOT WORK." NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMING, OR EVENT DETAILS WERE NOT AVAILABLE. DURING TESTING AT THE USER FACILITY, LINE D OF THE DEVICE CONTINUED TO DELIVER AFTER THE STOP KEY WAS PRESSED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE PUMP WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O-F 4000 PLUS 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK