BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    MDR report key: 1080803 · Received July 17, 2008

    Report

    Report Number
    2183502-2008-00194
    Event Type
    Injury
    Date Received
    July 17, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    FRN
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: REPORTER STATES AT THE TIME OF THE INCIDENT, NO ONE ADMITTED TO BOLUSING THE PT EVEN THOUGH THE PUMP HISTORY SHOWED EVIDENCE OF 2 PROGRAMMED BOLUSES. STATES IN 2008 A PERSON DID ADMIT TO ADMINISTRATING THE BOLUSES. UPON RECEIPT, THE DEVICE WAS EVALUATED. THE TAMPER SEAL WAS INTACT. THE EVAL COULD NOT DUPLICATE ANY UNINTENDED BOLUSES. STANDARD ACCURACY TESTS AND CALIBRATIONS WERE FOUND TO BE WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDFUSION 3500 SYRINGE INFUSION PUMP SYRINGE INFUSION PUMP FRN SMITHS MEDICAL MD (FORMERLY DELTEC, INC) * NA

    Patients

    Seq Age Sex Outcome Treatment
    1