BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT

    MDR report key: 11392176 · Received March 1, 2021

    Report

    Report Number
    9610825-2021-00046
    Event Type
    Malfunction
    Date Received
    March 1, 2021
    Report Date
    March 1, 2021
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS EVENT TWO OF B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE A THOROUGH SAMPLE ANALYSIS COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    PER THE (B)(6) POSTS REGARDING SPACE PUMPS: EVENT 2 - USER (B)(6). WATCH YOUR HEPARIN IF USING THE DRUG LIBRARY! THERE'S NO MAX FOR THE PUMP.. SO WHEN YOU PUT IN WEIGHT IT AUTO SETS YOUR DOSE AND DOES NOT MAX OUT AT THE 20 ML/HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292712 INFUSOMAT PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1