BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 11866063 · Received May 21, 2021

    Report

    Report Number
    9610825-2021-00183
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Report Date
    September 22, 2022
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K142596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT (B)(4). THE PUMP WAS NOT RETURNED FOR EVALUATION, AND THE DEVICE LOGS WERE NOT MADE AVAILABLE. FURTHER INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE WITHOUT A DEVICE FOR EVALUATION OR THE DEVICE LOGS. THE SAMPLE IS VALUABLE TOOL IN INVESTIGATING THE CAUSE OF THIS INCIDENT. IF THE DEVICE OR THE DEVICE LOGS DO BECOME AVAILABLE, THE COMPLAINT WILL BE REOPENED FOR FURTHER EVALUATION. ALL INFORMATION CONCERNING THIS REPORTED INCIDENT HAS BEEN INCLUDED IN OUR TREND ANALYSIS OF THE PRODUCT LINE.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. ADDITIONAL ATTEMPTS TO GET MORE INFORMATION ARE BEING MADE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: PUMP ALLOWING TO ADD MORE VOLUME WHEN THE INFUSION IS COMPLETE AND INFUSE ABOVE SET HARD LIMITS IN DRUG LIBRARY. PUMP DOES ALARM TO INDICATE THAT YOU ARE OVER THE SOFT LIMIT, BUT ALLOWS YOU TO OVERRIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762265 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown