BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 4000 WIRELESS SYRINGE INFUSION PUMP

    MDR report key: 16733068 · Received April 13, 2023

    Report

    Report Number
    3012307300-2023-04075
    Event Type
    Malfunction
    Date Received
    April 13, 2023
    Report Date
    April 26, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586040818
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER RESPONSE EMAIL RECEIVED WITH NEW 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-0191875 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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PUMP WAS NOT INVOLVED IN AN INCIDENT, AND NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PUMP CAUGHT ON FIRE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1479980 MEDFUSION 4000 WIRELESS SYRINGE INFUSION PUMP PUMP, INFUSION FRN ST PAUL 4000-0101-51 10610586040818

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown