BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    MDR report key: 14973653 · Received July 9, 2022

    Report

    Report Number
    3012307300-2022-13186
    Event Type
    Malfunction
    Date Received
    July 9, 2022
    Date of Event
    July 27, 2022
    Report Date
    November 1, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586041242
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OPERATOR OF DEVICE IS UNKNOWN. INITIAL REPORTER ALSO SENT REPORT TO FDA IS UNKNOWN. 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.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: A SAMPLE WAS RETURNED TO MANUFACTURING FOR INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED. VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE TAMPER SEALS WERE BROKEN OR REMOVED UPON RECEIPT, THE TOP CASE WAS CHIPPED ON THE FRONT CORNER AND THE RIGHT PLUNGER CASE WAS CRACKED. ERROR CODE WAS FOUND IN THE EHL (EVENT HISTORY LOG). THE CUSTOMER REPORTED ISSUE WAS DUPLICATED DURING THE INVESTIGATION. ROOT CAUSE OF THE REPORTED EVENT IS DUE TO NORMAL WEAR AND USE AS THE PARTS WERE OVER 10 YEARS OLD. REPLACED THE WORM COUPLING GEAR AND REPLACED THE STEPPER MOTOR AS A PREVENTIVE MEASURE. THE RETURNED PRODUCT IS BEYOND A YEAR FROM MANUFACTURE DATE AND THERE WAS NO INDICATION OF A MANUFACTURING DEFECT DURING THE INVESTIGATION, SO A DEVICE HISTORY RECORD DHR REVIEW WAS NOT REQUIRED. SERVICE HISTORY REVIEW IDENTIFIED THIS DEVICE HAS NOT BEEN IN FOR SERVICE IN THE PREVIOUS YEAR AND THERE WAS NO INDICATION OF A SERVICE ISSUE DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED AND ATTACHED ON 3 AUGUST 2022, UPDATED THE EVENT DATE, AND THE ISSUE WAS FOUND DURING ANNUAL PM (PREVENTIVE MAINTENANCE) TESTING. THERE WAS NO PATIENT INJURY. H6: EVENT PROBLEM AND EVALUATION CODES: UPDATES NOT REQUIRED. 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. D4: CORRECTION: CATALOG NUMBER: 3500-0600-01. D4: CORRECTION: MODEL NUMBER: 3500. G5: CORRECTION: PREMARKET (510K) NUMBER: K111386. H4: CORRECTION: DEVICE MANUFACTURING DATE: 15-MAY-2015.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE GOT A MOTOR RATE ERROR DURING THE OCCLUSION TEST. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2396759 MEDFUSION 3500 SYRINGE INFUSION PUMP PUMP, INFUSION FRN ST PAUL 3500 10610586041242

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown