BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 13995075 · Received April 4, 2022

    Report

    Report Number
    9610825-2022-00103
    Event Type
    Malfunction
    Date Received
    April 4, 2022
    Report Date
    June 9, 2022
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046964660887
    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 COMPLAINT IS UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). A REVIEW OF THE LOGS FROM THE DEVICE DID NOT CONFIRM THE REPORTED DEFECT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: PATIENT ORDER FOR D5W 1,000 ML WITH SODIUM BICARBONATE 100 MEQ IV SOLUTION TO INFUSE AT 100 ML/HOUR TO TREAT LACTIC ACIDOSIS. AT 1424 RN DOCUMENTED IN MAR SHE HUNG A NEW 1000 ML BAG OF D5W WITH SODIUM BICARB TO INFUSE AT 100 ML/HR. THE CHARGE NURSE DOCUMENTED SHE RESPONDED TO THE PATIENT'S ALARMING IV PUMP INDICATING THE BICARB DRIP NEEDED VOLUME ADDED TO RUN. SHE NOTED THE IV PUMP RATE FOR THE BICARB DRIP WAS SET AT 1,000 ML/HOUR, INSTEAD OF THE ORDERED RATE OF 100 ML/HOUR. SHE TURNED OFF THE PUMP AND NOTIFIED THE INTENSIVIST. NO ADDITIONAL ORDERS WERE GIVEN. AT 1717, RN DOCUMENTED SHE HUNG ANOTHER NEW 1000 ML BAG OF D5W WITH SODIUM BICARB. AT 9142, RN DOCUMENTED SHE GAVE A 2L LR BOLUS, AND STARTED BICARB DRIP. NO DOCUMENTED EVIDENCE THAT 1,000 ML OF BICARB DRIP INFUSED IN APPROXIMATELY 3 HOURS INSTEAD OF 10 HOURS. NO CHANGE IN PATIENT'S CLINICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604401 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG 8713051U 04046964660887

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown