BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT

    MDR report key: 11170436 · Received January 14, 2021

    Report

    Report Number
    9610825-2020-00368
    Event Type
    Malfunction
    Date Received
    January 14, 2021
    Report Date
    February 8, 2021
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE SAMPLE WAS PROVIDED FOR AN EXAMINATION AND ROOT CAUSE ANALYSIS IN OUR SERVICE LABORATORY IN MELSUNGEN. THE HISTORY FILES WERE READ OUT AND ANALYZED. ONLY SOME PRESSURE ALARMS AND DRIVE BLOCKED ALARMS COULD BE FOUND. NO FURTHER MALFUNCTIONS COULD BE DETECTED. DURING THE VISUAL INSPECTION OF THE INFUSOMAT SPACE, ALL COVER CAPS ON THE SCREW PILLARS AS WELL AS THE SEAL ON THE LOWER HOUSING WERE AVAILABLE AND UNDAMAGED. NO DAMAGES ON THE HOUSING PARTS COULD BE FOUND. AS PART OF THE FUNCTIONAL CHECK THE SELF TEST OF THE INFUSOMAT SPACE COULD BE SUCCESSFULLY PERFORMED. AN INFUSOMAT SPACE LINE COULD BE INSERTED AND WAS RECOGNIZED BY THE PUMP. AFTER THE LINE SELECTION IT WAS POSSIBLE TO BRING THE PUMP IN OPERATION. A SETTING OF AN INFUSION THERAPY WAS ENTERED AND THE DELIVERY MODE WAS STARTED. AFTER SOME SECONDS THE INFUSION WAS INTERRUPTED BY A "DRIVE BLOCKED" ERROR. CAUSED OF THE OCCURRED ERROR NO FLOW MEASUREMENT COULD BE PERFORMED. THE DEVICE WAS COMPLETE DISASSEMBLED TO INVESTIGATE THE INSIDE OF THE DEVICE. THE REASON OF THE ERROR WAS A BOLT WITH A WRONG POSITION. THE BOLT WAS NOT IN PROPERLY POSITION IN THE PUMP INNER FRAME. DUE THE SERIAL NUMBER IT WAS POSSIBLE TO IDENTIFIED THE A PRODUCTION DATE AT NOVEMBER 2015 AND THUS IT ISN´T NOT A NEW DEVICE AND NO PRODUCTION MISTAKE COULD DETECTED. THE WRONG POSITION OF THE BOLT COULD ONLY BE HAPPENED DUE OF A SHOCK TO THE FRAME AND THE PLASTIC BRACKET CRACK. THE COMPLAINT COULD NOT BE CONFIRMED. THE MENTIONED FLOW DEVIATION MAY HAD BEEN CAUSED BY THE BROKEN INNER FRAME. BECAUSE THE SLIDE GUIDE CANNOT PUT ENOUGH PRESSURE ON THE TUBE TO PREVENT THE FLUID FROM RUNNING. THE DAMAGE WAS CAUSED BY WRONG HANDLING BY USER.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) INTERNAL REPORT (B)(4). THE DEVICE HAS BEEN REQUESTED TO SEND IT FOR INVESTIGATION TO BBM LABORATORY IN (B)(6). IF AN INVESTIGATION REPORT IS AVAILABLE, A FOLLOW-UP REPORT WILL CREATED. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6): "UNDERINFUSION" CUSTOMER INFORMATION: UNIT IS UNDER-INFUSING BY 11%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65503 INFUSOMAT PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1