BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT

    MDR report key: 11273990 · Received February 3, 2021

    Report

    Report Number
    9610825-2021-00012
    Event Type
    Malfunction
    Date Received
    February 3, 2021
    Report Date
    March 30, 2021
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046964660887
    PMA / PMN Number
    K142596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). FAILURE ANALYSIS AND INVESTIGATION RESULTS DID NOT CONFIRM THE REPORTED ISSUE. UPON RECEIPT THE ACTUAL PUMP INVOLVED WAS VISUALLY AND FUNCTIONALLY INSPECTED. THREE (3) VOLUMETRICS OF 250ML/HR AND 25ML WERE PERFORMED AND TESTED IN SPEC. THE PUMP OPERATED AS INTENDED AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. BASED ON THE RESULTS OF THE INVESTIGATION, NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    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. 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: PUMP NOT DRIPPING MEDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167688 INFUSOMAT PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG 8713051U 04046964660887

    Patients

    Seq Age Sex Outcome Treatment
    1