BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 20857738 · Received December 5, 2024

    Report

    Report Number
    9610825-2024-00843
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    June 9, 2024
    Report Date
    February 14, 2025
    Manufacturer
    B. BRAUN AVITUM AG
    Product Code
    FRN
    UDI-DI
    04046964660887
    PMA / PMN Number
    K142596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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 INTERNAL REPORT NUMBER (B)(4). NO SAMPLE AND NO EVENT LOGS WERE PROVIDED FOR EVALUATION. BASED ON THE DATA FROM THE INVESTIGATION WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: PT ARRIVED AS TRANSFER FROM OTHER HOSPITAL, REQUIRING PRESSORS AND BLOOD PRODUCTS DURING TRANSPORT R/T HYPOTENSION. UPON ARRIVAL, TRANSITIONED TO B BRAUN PUMPS WITH LEVO, VASO AND EPI; MTE INITIATED FOR CONTINUING HYPOTENSION. PRIMARY RN AND ADDITIONAL RN WERE AT BEDSIDE WHEN NOTICED HYPOTENSIVE TO MAP OF 50S AND DECREASING. UPON INVESTIGATION, LEVO INFUSION HAD TRANSITIONED TO KVO WITHOUT AUDIBLE ALARM AND VOLUME STILL LEFT ON PUMP. REQUIRED ADDITIONAL BLOOD PRODUCTS, REPROGRAMMING PUMP AND UPWARD TITRATION OF OTHER VASOACTIVES TO PREVENT FURTHER HYPOTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2289767 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN AVITUM AG 04046964660887

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male