BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 11692548 · Received April 20, 2021

    Report

    Report Number
    9610825-2021-00123
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    April 7, 2021
    Report Date
    September 9, 2022
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046963716752
    PMA / PMN Number
    K083689
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    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 ON THE REPORTED EVENT 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 USER FACILITY: THE PUMP MOVES AND WORKS BUT THE MED DOES NOT DRIP FROM THE BOTTLE BUT YOU CAN SEE AIR BUBBLE GOING IN FROM THE VENT. IT ALSO DOES NOT SET OFF ANY ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591796 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG 8713050U 04046963716752

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown