BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI-FLOW MODEL 4000 PLUS

    MDR report key: 1032902 · Received April 23, 2008

    Report

    Report Number
    2921482-2008-00135
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    January 1, 2008
    Report Date
    April 1, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K882594
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE DID NOT DELIVER ON LINE D. THE PUMP WAS RETURNED TO THE MEDICAL ASSISTANT WITH AN UNSIGNED NOTE THAT STATED, "WILL NOT INFUSE ON LINE D." 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 WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK