BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 4000 PUMP

    MDR report key: 16755906 · Received April 17, 2023

    Report

    Report Number
    3012307300-2023-04228
    Event Type
    Malfunction
    Date Received
    April 17, 2023
    Report Date
    May 1, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    15019517069624
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    OTHER, 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-0192172 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARDS ANY REPORTS ASSOCIATED WITH IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE MEDFUSION PUMP EXHIBITED A WATCHDOG AND PRIMARY ERROR. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2279674 MEDFUSION 4000 PUMP PUMP, INFUSION FRN ST PAUL 4000-0106-01 15019517069624

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown