BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    MDR report key: 1812671 · Received August 18, 2010

    Report

    Report Number
    2183502-2010-00330
    Event Type
    Malfunction
    Date Received
    August 18, 2010
    Manufacturer
    SMITHS MEDICAL MD
    Product Code
    FRN
    PMA / PMN Number
    K040899
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: ON (B)(4) 2010, USER FACILITY WAS CONTACTED AND A NURSE IN THE (B)(4) CONFIRMED NO PT INJURY OR ADVERSE EVENT OCCURRED. AS OF (B)(4) 2010, THE DEVICE HAS NOT BEEN MADE AVAILABLE TO THE MANUFACTURER FOR PRODUCT EVALUATION. THE BIO MEDICAL ENGINEERING DEPT AT THE USER FACILITY REPORTED THAT THEY EVALUATED THE DEVICE ON (B)(4) 2010 AND THE DEVICE PASSED ALL THEIR TESTING FOR ACCURACY AND DELIVERY. THEY STATED THAT THE DEVICE WAS PLACED BACK IN CIRCULATION AT THE FACILITY WITHOUT A PLAN TO RETURN THE DEVICE TO THE MANUFACTURER.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDFUSION 3500 SYRINGE INFUSION PUMP SYRINGE INFUSION PUMP FRN SMITHS MEDICAL MD 3500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1