BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSOMAT®

    MDR report key: 18788376 · Received February 27, 2024

    Report

    Report Number
    9610825-2024-00091
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    January 25, 2024
    Report Date
    September 26, 2024
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046964660887
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    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 TO B. BRAUN MEDICAL FOR EVALUATION BUT THE LOGS WERE PROVIDED FOR REVIEW. LOG REVIEW SHOWS ON (B)(6) 2024 A CONTINUING 125ML/HR PIGGYBACK INFUSION WITH VOLUME INFUSED TO 280.67ML. AT 6:36PM AN INFUSION START AND AT 7:51PM PRESSURE ALARM STOPPED THE INFUSION WITH A VOLUME INFUSED TO 434.94ML. AT 7:55PM AN INFUSION START AND AT 7:56PM AN INFUSION STOP WITH A VOLUME INFUSED TO 435.21ML, PUMP WAS PLACED ON STANDBY, THEN BROUGHT OUT OF STANDBY, THEN DOOR WAS OPENED, WITH NO FURTHER INFUSION ACTIVITY TAKING PLACE. ALL INFORMATION CONCERNING THIS REPORTED INCIDENT HAS BEEN INCLUDED IN OUR TREND ANALYSIS OF THE PRODUCT LINE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: PUMP BEGAN SPONTANEOUSLY BOLUSING MEDICATION, EVEN THOUGH RATE ON PUMPN WAS 125CC HR. -TRIED RELOADING TUBING-STILL MED DRAINING AT RAPID RATE THROUGH PUMP (APPEARED AS IF DRAINING BY GRAVITY). PT HARMED - ADVERSE MED EVENT AS A RESULT. SWITCHED TUBING (AND ZERO PUMP) AND ISSUE RESOLVED DESPITE KEEPING SAME PUMP AN PUMP SETTING. (RE.ONLY CHANGED THE IV TUBING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655935 INFUSOMAT® PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG 97041808K2 04046964660887

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown