BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    MDR report key: 17168107 · Received June 20, 2023

    Report

    Report Number
    3012307300-2023-06422
    Event Type
    Malfunction
    Date Received
    June 20, 2023
    Report Date
    September 12, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586032318
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D5 IS UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. 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

    OTHER TEXT: IT HAS BEEN DETERMINED THAT COMPLAINT FILE CC-0182984 WITH A MANUFACTURING REPORT NUMBER OF 3012307300-2023-06422 WAS REPORTED IN ERROR. PLEASE DISREGARD THE PREVIOUS SUBMISSION. ANY ADDITIONAL REPORTING WILL BE CONDUCTED UNDER THE APPLICABLE FILE.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT THE PUMP HAS AN INVALID SYRINGE ISSUE. NO PATIENT INJURY REPORTED. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206270 MEDFUSION 3500 SYRINGE INFUSION PUMP PUMP, INFUSION FRN ST PAUL 3500-500 10610586032318

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown