BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP

    MDR report key: 16156819 · Received January 13, 2023

    Report

    Report Number
    3012307300-2023-00443
    Event Type
    Malfunction
    Date Received
    January 13, 2023
    Report Date
    March 10, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586040818
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER TEXT: 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-0181845 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARDS 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. OPERATOR OF DEVICE IS UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A RETURNED ORDER SERVICE, IT WAS DETERMINED THAT THE SYRINGE PLUNGER WAS NOT IN PLACE. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1752064 MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP PUMP, INFUSION FRN ST PAUL 4000 10610586040818

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown