BEUDAMED
    FDA Adverse Event Death Summary report: N

    IRADIMED

    MDR report key: 15195904 · Received August 9, 2022

    Report

    Report Number
    3005053560-2022-00003
    Event Type
    Death
    Date Received
    August 9, 2022
    Date of Event
    July 11, 2022
    Report Date
    August 9, 2022
    Manufacturer
    IRADIMED CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K143369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2022 IT WAS REPORTED THAT A PATIENT DEATH OCCURRED DUE TO UNDER INFUSION. THE BIOMEDICAL ENGINEER INDICATED THAT THEY WERE NOT CERTAIN WHICH DEVICE THE EVENT OCCURRED ON, BUT WOULD THEY WOULD RETURN TWO SYSTEMS SO THAT IRADIMED COULD EVALUATE THEM AND TRY TO DETERMINE WHICH SYSTEM WAS INVOLVED IN THE EVENT. THE TWO SYSTEMS (4 PUMPING CHANNELS) WERE RECEIVED FROM THE SITE ON 07/29/2022. EACH 2 CHANNEL SYSTEM IS MADE UP OF A MRIDIUM 3860+ A-CHANNEL AND A 3861 B-CHANNEL PUMP. THE SERIAL NUMBERS THAT WERE RETURNED WERE: A-CHANNEL (B)(4). B-CHANNEL (B)(4). BOTH SYSTEMS APPEAR IN OVERALL GOOD PHYSICAL CONDITION WITH NO OBVIOUS SIGNS OF MIS-USE OR NEGLECT. THE A CHANNEL PUMP ACTS AS THE USER INTERFACE AND CONTROL FOR BOTH THE A-CHANNEL AND IT'S PAIRED B-CHANNEL. THE EVENT HISTORY LOG FOR BOTH THE A AND B CHANNEL PAIR ARE STORED ON THE A-CHANNEL PUMP. SINCE THE FACILITY WAS UNABLE TO IDENTIFY WHICH PUMP SYSTEM WAS INVOLVED IN THE EVENT BOTH A-CHANNEL EVENT LOGS WERE DOWNLOADED FOR REVIEW. ADDITIONALLY, SINCE THE FACILITY WILL NOT SHARE ANYTHING ABOUT THE EVENT OTHER THAN THEY SEQUESTERED THE PUMP FOLLOWING THE EVENT, THE LOG WAS REVIEWED TO DETERMINE THE LAST USE OF THE PUMP WITH THE HYPOTHESIS THAT THIS WOULD BE THE USE INVOLVED WITH THE PATIENT EVENT. SERIAL (B)(4) WHICH WAS PAIRED WITH SERIAL NUMBER (B)(4) WAS LAST USED ON (B)(6) 2022, ALTHOUGH IT WAS TURNED ON AND OFF SEVERAL TIMES ON (B)(6) 2022, THERE IS NO EVIDENCE OF IT BEING PROGRAMMED FOR AN ACTUAL INFUSION ON THOSE DATES. WHEN RUN ON (B)(6) 2022, THE A CHANNEL WAS USED IN A WEIGHT BASED DILUTION FOR AN EFFECTIVE RATE OF 28.6 ML/HR. THE INFUSION APPEARED TO DELIVER AS PROGRAMMED BASED ON THE CALCULATED VOLUME REPORTED IN THE EVENT LOG. THE B CHANNEL WAS ALSO USED IN A WEIGHT BASED DILUTION FOR AN EFFECTIVE RATE OF 9.5 ML/HR AND IT TOO APPEARS TO HAVE DELIVERED AS PROGRAMMED. SERIAL (B)(4) WHICH WAS PAIRED WITH SERIAL (B)(4) WAS LAST USED ON (B)(6) 2022. THE A CHANNEL WAS PROGRAMMED IN A RATE/VOLUME MODE TO RUN AT 469 ML/HR WITH A TOTAL VOLUME TO BE INFUSED (VTBI) OF 250 ML. THIS INFUSION RAN AS EXPECTED BASED ON THE PUMPS REPORTED VOLUMES IN THE EVENT LOG. CHANNEL B WAS PROGRAMMED TO RUN IN A RATE/VOLUME MODE AT 82.5 ML/HR, BUT THE VTBI WAS NOT ENTERED. THE BUTTON TO PROGRAM IT WAS PRESSED BECAUSE THE VALUE WENT TO ITS DEFAULT VALUE OF 0.1 ML, BUT NO ACTUAL VTBI VALUE WAS ENTERED. THE START BUTTON WAS PRESSED WITH THE 0.1 ML PROGRAMMING AND THE PUMP SCREEN WOULD HAVE CHANGED TO THE RUNNING SCREEN SHOWING THE INFUSION TIME OF 4 SECONDS COUNTING DOWN. THE USER INTERACTED WITH THE PUMP AND RESTARTED THE INFUSION, BUT DID NOT ADJUST THE DESIRED VTBI, SO ANOTHER 0.1 ML INFUSION WAS STARTED AND COMPLETE ALMOST IMMEDIATELY. WITHOUT FURTHER INFORMATION ABOUT THE EVENT, IT IS BELIEVED THAT THE EVENT OCCURRED ON THE B-CHANNEL OF THIS SYSTEM, AND THAT THE UNDER INFUSION IS THE RESULT OF USER ERROR WHEN PROGRAMMING THE PUMP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE, A IRADIMED INFUSION PUMP UNDER INFUSED RESULTING IN A PATIENT DEATH. THE HOSPITAL WAS UNWILLING TO SHARE ANY ADDITIONAL INFORMATION ABOUT THE EVENT. THE DATE OF THE EVENT IS UNKNOWN AS ARE ALL OTHER DETAILS ABOUT THE PATIENT AND MEDICATION INVOLVED. IT WAS ALSO REPORTED THAT THE INFUSION PUMP WAS REMOVED FROM SERVICE, BUT THAT IT WAS STORED WITH ANOTHER IRADIMED INFUSION PUMP AND THE HOSPITAL NO LONGER KNOWS WHICH PUMP IS RELATED TO THE EVENT. BOTH PUMPS WHICH ARE TWO INTEGRATED PUMPING CHANNELS EACH WILL BE RETURNED TO IRADIMED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294998 IRADIMED INFUSION PUMP FRN IRADIMED CORPORATION 3861

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death