BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    MDR report key: 16629992 · Received March 28, 2023

    Report

    Report Number
    3012307300-2023-03110
    Event Type
    Malfunction
    Date Received
    March 28, 2023
    Report Date
    May 8, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586041242
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: EVALUATION: TAMPER SEAL REMOVED/BROKEN: YES, ON BOTTOM CASE CHECK SYRINGE PLUNGE SENSOR ERROR WAS FOUND AT POWER UP AND FAILED PLUNGER SENSOR TEST. FLUID INGRESSION WAS FOUND INSIDE OF PLUNGER ASSEMBLY. REPLACED THE WHOLE PLUNGE ASSEMBLY ALSO REPLACED PLUNGER TUBE AND PLUNGER CABLE. PERFORMED PM MAINTENANCE AND ALL FUNCTIONAL TESTING. ROOT CAUSE IS DUE TO FLUID INGRESSION INSIDE THE PLUNGER ASSEMBLY CAUSED BY CUSTOMER. PRODUCT IS BEYOND A YEAR FROM MANUFACTURE DATE AND THERE WAS NO INDICATION OF A MANUFACTURING DEFECT DURING THE INVESTIGATION, SO A DHR REVIEW WAS NOT PERFORMED. SERVICE HISTORY REVIEW IDENTIFIED THIS DEVICE WAS LAST SERVICED IN (B)(6) 2022 PER RO #1252019 AND IS NOT RELATED TO THE CUSTOMER'S COMPLAINT.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PUMPS PLUNGER SENSOR FAILED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554613 MEDFUSION 3500 SYRINGE INFUSION PUMP PUMP, INFUSION FRN ST PAUL 3500-0600-01 10610586041242

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown