BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION

    MDR report key: 16354224 · Received February 10, 2023

    Report

    Report Number
    3012307300-2023-01147
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Report Date
    April 3, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586032318
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE PERFORMING A REVIEW OF ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER, THERE WAS NO PATIENT INVOLVEMENT, THEREFORE, NO PATIENT DEATH, SERIOUS INJURY, AND NO EVIDENCE OF A REPORTABLE PRODUCT MALFUNCTION. THE HAZARDOUS SITUATION FOR THE GIVEN COMPLAINT DEVICE WOULD NOT LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. FILE CC-0183457 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARD ANY REPORTS ASSOCIATED WITH IT.

    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 THAT THE PUMP MAKES A LOT OF NOISE WHEN TURNED ON OR DELIVERING THE DOSE. NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57741 MEDFUSION PUMP, INFUSION FRN ST PAUL 3500-500 10610586032318

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown