BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 4000 WIRELESS SYRINGE INFUSION PUMP

    MDR report key: 15637571 · Received October 20, 2022

    Report

    Report Number
    3012307300-2022-25297
    Event Type
    Malfunction
    Date Received
    October 20, 2022
    Date of Event
    March 15, 2018
    Report Date
    October 20, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    15019517069624
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. THE SAMPLE WAS RECEIVED IN EXCELLENT CONDITION. NO TAMPER SEAL WAS REMOVED OR BROKEN. ERROR HISTORY LOG REVIEW FOUND A FORCE SENSOR TEST ERROR. POWER UP PROCESS WAS PERFORMED AND THE FORCE SENSOR WAS CHECKED AND TESTED. THE SAMPLE FAILED FORCE SENSOR READING AT 0.00 POUNDS. THE ROOT CAUSE OF THE REPORTED ISSUE WAS FOUND TO BE DUE TO THE FORCE SENSOR THAT WAS OUT OF CALIBRATION. ACTIONS WERE TAKEN TO MITIGATE THE REPORTED ISSUE: PUMP WAS CONVERTED TO LOANER AFTER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD A FORCE AT ZERO FAILURE WITH -0.92 POUNDS. MAY HAVE DEFECTIVE BATTERY FROM 2032938. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2002645 MEDFUSION 4000 WIRELESS SYRINGE INFUSION PUMP ACCESSORIES, PUMP, INFUSION FRN ST PAUL 4000-0106-01 15019517069624

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown