BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITHS MEDICAL MEDFUSION 3500 SYRINGE PUMP

    MDR report key: 9604845 · Received January 18, 2020

    Report

    Report Number
    3012307300-2020-00544
    Event Type
    Malfunction
    Date Received
    January 18, 2020
    Report Date
    January 18, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RETURNED DEVICE WAS RECEIVED WITH A COUNTERFEIT CASE TOP. CASE BOTTOM CRACKED BY L-BRACKET. NO EVIDENCE OF REPORTED PROBLEM IN EVENT LOG WAS FOUND. DURING THE EVALUATION OF THE DEVICE THE REPORTED CONDITION COULD NOT BE DUPLICATED PRIMARY AUDIBLE ALARM, BUT FOUND SPEAKER INSTALLED UPSIDE DOWN. THE PUMP IS NOT SAVING MOST RECENT ALARM AND INFUSION HISTORY. THE CUSTOMER REPORTED CONDITION WAS NOT CONFIRMED. NO FAULT FOUND.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL MEDFUSION 3500 SYRINGE PUMP, AUDIBLE ALARM POST/ CHANGED THE SPEAKER ALREADY/ NOT BEING PUT ON THE ALARM LOG. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67850 SMITHS MEDICAL MEDFUSION 3500 SYRINGE PUMP PUMP, INFUSION. PRODUCT CODE: FRN FRN SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1