BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    MDR report key: 15006071 · Received July 13, 2022

    Report

    Report Number
    3012307300-2022-13310
    Event Type
    Malfunction
    Date Received
    July 13, 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
    AR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR ANALYSIS. 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

    H3: DEVICE EVALUATED BY MANUFACTURER: UPDATED. H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H10: 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 SEAL WAS MISSING ON THE PLUNGER HEAD, THERE WAS NO NOTICEABLE EXTERNAL DAMAGE FOUND. ERROR CODE WAS FOUND IN THE EHL (EVENT HISTORY LOG). THE CUSTOMER REPORTED ISSUE WAS CONFIRMED DURING THE INVESTIGATION AS THE FORCE SENSOR WAS OUT OF CALIBRATION. ROOT CAUSE OF THE REPORTED EVENT IS UNABLE TO BE DETERMINED AS THERE WAS NO EXTERNAL DAMAGE NOTED WITH THE FORCE SENSOR. REPLACED THE FORCE SENSOR AS A PREVENTATIVE 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 PERFORMED. SERVICE HISTORY REVIEW IDENTIFIED THIS DEVICE HAS NOT BEEN IN FOR SERVICE PREVIOUSLY., CORRECTED DATA: D4: CORRECTION: MODEL NUMBER: 3500, H4: CORRECTION: DEVICE MANUFACTURE DATE: 10/11/2017.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: B5: ADDITIONAL INFORMATION RECEIVED ON 27-JUL-2022 VIA EMAIL AND ATTACHED TO COMPLAINT OBJECT: NO PATIENT INVOLVEMENT. DEVICE WAS DROPPED. H6: UPDATE: EVENT PROBLEM DEVICE CODE:A051203 [4014] - DEVICE FELL C133516.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS A SYSTEM FAILURE FORCE SENSOR TEST. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2348541 MEDFUSION 3500 SYRINGE INFUSION PUMP PUMP, INFUSION FRN ST PAUL 3500 10610586041242

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown