BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT

    MDR report key: 12306466 · Received August 11, 2021

    Report

    Report Number
    9610825-2021-00321
    Event Type
    Malfunction
    Date Received
    August 11, 2021
    Report Date
    September 23, 2021
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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). RESULTS: A VISUAL INSPECTION WAS PERFORMED. NO VISIBLE DAMAGE WERE FOUND. A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSED THE SELF TEST. A SPACE LINE WAS INSERTED, AND THE PUMP IDENTIFIED THE LINE AND IT COULD BE SELECTED FROM THE MENU. IT WAS POSSIBLE TO PUT THE PUMP IN OPERATION. THE DEVICE HISTORY FILES WERE READ AND ANALYZED. THE INFUSION WAS STARTED. DURING THE INFUSION DIFFERENT DROP ALARMS OCCURRED (TOO MANY DROPS, TOO FEW DROPS, FLOW-ALARM). THE REASON FOR THE ALARMS COULD NOT BE CLARIFIED. A DELIVERY ACCURACY MEASUREMENT ACCORDING TO IEC 60601-2-24 WAS ARRANGED. HERE A NOMINAL FEED RATE OF 100 ML/H WAS CHOSEN. THE ASSESSED MEAN DEVIATION "A" OF THE SECOND OPERATING HOUR WAS MEASURED AND RESULTED IN A VALUE OF -8,87%. A INFUSION WITH THE DROP SENSOR WAS PERFORMED. AT THIS JUNCTURE COULD THE ERROR DESCRIPTION REPRODUCE. AFTER A FEW MINUTES THE PUMP ALERTS WITH A "TOO MANY DROPS" ALARM. THE DEVICE WAS DISASSEMBLED AND THE INSIDE WAS INVESTIGATED. THE PLASTIC CLIP FOR THE PUMP FRAME ON THE INNER FRAME WAS BROKEN. THE DAMAGE IS DUE TO AN IMPACT DAMAGE. THE COMPLAINT COULD NOT BE CONFIRMED. THE PLASTIC CLIP FOR THE PUMP FRAME ON THE INNER FRAME WAS BROKEN. THE DAMAGE IS DUE TO AN IMPACT DAMAGE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT IS UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. 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): "PECULIAR DELIVERY OF AN INFUSION PUMP". ACCORDING TO THE CUSTOMER: PECULIAR DELIVERY OF AN INFUSION PUMP. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206711 INFUSOMAT PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1