BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-F 4000 PLUS

    MDR report key: 3061610 · Received April 11, 2013

    Report

    Report Number
    9615050-2013-00681
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    January 3, 2013
    Report Date
    March 15, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K882594
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT ISOLATED OR IDENTIFIED BY SERIAL NUMBER; THEREFORE, IT WILL NOT BE RETURNED FOR INVESTIGATION. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PT RECEIVED MORE MEDICATION THAN INTENDED. ON (B)(6) 2013, AT AN UNSPECIFIED TIME, AN UNSPECIFIED LINE OF THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF CYTABARINE, FOR DURATION OF 24 HOURS, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. IT WAS REPORTED THAT THE PUMP PROGRAMMING WAS CONFIRMED TO BE CORRECT BY A REPORTED MULTIPLE NURSES. ON (B)(6) 2013, AT 1600, IT WAS REPORTED THAT THE DEVICE ALARMED AT THE DELIVERY WAS COMPLETE. AT THAT TIME, THE NURSE NOTED THE MEDICATION CONTAINER WAS EMPTY. THE CUSTOMER CONTACT INDICATED THE DELIVERY HAD COMPLETED 2 HOURS EARLIER THAN EXPECTED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155434 O-F 4000 PLUS 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK