BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 4000 PUMPS

    MDR report key: 13804374 · Received March 18, 2022

    Report

    Report Number
    3012307300-2022-04667
    Event Type
    Malfunction
    Date Received
    March 18, 2022
    Report Date
    April 4, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). NO CAUSES OR POTENTIAL CAUSES OF THE CUSTOMER'S REPORTED PROBLEM WERE FOUND DURING THE REVIEW OF SERVICE AND REPAIR RECORDS. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. VISUAL INSPECTION SHOWED THE TOP CASE WAS CRACKED BY THE FRONT LEFT BOTTOM CORNER. A REVIEW OF THE EVENT HISTORY LOG (EHL) IDENTIFIED FIRMWARE MISMATCH. DURING THE FUNCTIONAL TESTING THE REPORTED ISSUE WAS ABLE TO BE DUPLICATED. REPROGRAMMING FROM BASE UNIT (BOTTOM INTERCONNECT BOARD) TO TOP UNIT (MAIN BOARD) WAS INCOMPLETE. CUSTOMER MUST HAVE TRIED TO UPDATE FIRMWARE THROUGH WIRELESS NETWORK AND DID NOT COMPLETE UPLOAD PROCESS. THE ROOT CAUSE OF THIS ISSUE WAS DUE TO THE CUSTOMER NETWORK SYSTEM SOFTWARE DOWNLOAD TO THE PUMP WAS NOT COMPLETED (BASE TO HEAD) BECAUSE THE CUSTOMER SHUTDOWN THE PUMP BEFORE COMPLETION OF THE SOFTWARE UPDATE. CUSTOMER IGNORED PUMP DISPLAYED INSTRUCTIONS NOT TO TURN OFF PUMP UNTIL SOFTWARE UPDATE IS COMPLETE. UPLOAD VERSION 1.5.1 TO THE BASE UNIT (INTERCONNECT BOARD) AND REBOOTED THE PUMP'S HEAD (MAIN BOARD) BY PERFORMING POWER POINT PROCESS. UPLOADED CUSTOMER SOFTWARE VERSION 1.6.1 ON THE PUMP.

    Description of Event or Problem · 0

    ORACLE RO 1213671:FIRMWARE MISMATCH ERROR.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED VIA EMAIL: INCIDENT DID NOT OCCURRED WHILE IN USE WITH A PATIENT. NO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39376 MEDFUSION 4000 PUMPS PUMP, SYRINGE INFUSION FRN ST PAUL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown