BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 23241615 · Received October 8, 2025

    Report

    Report Number
    2016493-2025-120424
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    September 3, 2025
    Report Date
    November 19, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 0

    CORRECTION: IT WAS DETERMINED THROUGH INVESTIGATION OF THE RETURNED DEVICES THAT THE INITIALLY REPORTED SUSPECT DEVICE REPORTED UNDER MANUFACTURER REPORT NUMBER 2016493-2025-120424 IS A CONCOMITANT. PLEASE REFER TO MANUFACTURER REPORT NUMBER 2016493-2025-120423, 2016493-2025-120428 WHICH CAPTURED THE CORRECT SUSPECT DEVICE PER INVESTIGATION REPORT."

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE INFUSING EPINEPHRINE THE LVP MODULE (CHANNEL D) "TURNED ON BY ITSELF AND STARTED TO INFUSE EPINEPHRINE AT A RATE OF 75ML/HR." PER REPORT, THE DEVICE WAS TURNED OFF AGAIN AND ABOUT A HALF HOUR LATER IT TURNED ON AGAIN. ONE PCU AND 4 LVPS WERE INVOLVED AT THE TIME OF THE EVENT. LINES AND MEDICATIONS WERE VERIFIED TO BE CORRECT. THE PATIENT EXPERIENCED A HEART RATE INCREASE, BUT NO HARM. ADDITIONAL INFORMATION PROVIDED: THE CUSTOMER STATES "WHAT WE WERE ABLE TO IDENTIFY: THE PUMP WAS SOMEHOW LINKED TO A PATENT AT ANOTHER (FACILITY B) USING THE SAME ALARIS FORMULARY SERVER, EPIC SERVER, AND WIRELESS NETWORK SSID SO A PUMP FROM ANY OF OUR HOSPITAL CAN GET ON THE NETWORK AT ANY FACILITY SITE. WE DO NOT USE THE PATIENT OPERABILITY FEATURE AT FACILITY A, BUT THEY DO AT FACILITY B. WHAT WE SUSPECT IS THAT THE PUMP WAS ON A PATIENT AT FACILITY B AND THEN THE PUMP WAS RETURNED TO FACILITY A WHERE IT WAS USED ON AN OPERATING ROOM CASE ON (B)(6) 2025, AND WHEN PROGRAMMED FOR THIS NEW PATIENT "NO" WAS ENTERED WHICH LEFT THE PREVIOUS PATIENT STILL ENTERED IN THE PUMP. IN OUR EPIC SYSTEM IT SHOWS DATA GOING INTO EPIC FOR A PATIENT AT FACILITY B AND THAT THE PUMP WAS AT FACILITY B ON (B)(6) 2025. BOTH DAYS IT WAS AT FACILITY A.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE INFUSING EPINEPHRINE THE LVP MODULE (CHANNEL D) "TURNED ON BY ITSELF AND STARTED TO INFUSE EPINEPHRINE AT A RATE OF 75ML/HR." PER REPORT, THE DEVICE WAS TURNED OFF AGAIN AND ABOUT A HALF HOUR LATER IT TURNED ON AGAIN. ONE PCU AND 4 LVPS WERE INVOLVED AT THE TIME OF THE EVENT. LINES AND MEDICATIONS WERE VERIFIED TO BE CORRECT. THE PATIENT EXPERIENCED A HEART RATE INCREASE, BUT NO HARM. ADDITIONAL INFORMATION PROVIDED: THE CUSTOMER STATES "WHAT WE WERE ABLE TO IDENTIFY: THE PUMP WAS SOMEHOW LINKED TO A PATENT AT ANOTHER (FACILITY B) USING THE SAME ALARIS FORMULARY SERVER, EPIC SERVER, AND WIRELESS NETWORK SSID SO A PUMP FROM ANY OF OUR HOSPITAL CAN GET ON THE NETWORK AT ANY FACILITY SITE. WE DO NOT USE THE PATIENT OPERABILITY FEATURE AT FACILITY A, BUT THEY DO AT FACILITY B. WHAT WE SUSPECT IS THAT THE PUMP WAS ON A PATIENT AT FACILITY B AND THEN THE PUMP WAS RETURNED TO FACILITY A WHERE IT WAS USED ON AN OPERATING ROOM CASE ON SEPTEMBER 3, 2025, AND WHEN PROGRAMMED FOR THIS NEW PATIENT "NO" WAS ENTERED WHICH LEFT THE PREVIOUS PATIENT STILL ENTERED IN THE PUMP. IN OUR EPIC SYSTEM IT SHOWS DATA GOING INTO EPIC FOR A PATIENT AT FACILITY B AND THAT THE PUMP WAS AT FACILITY B ON SEPTEMBER 3, 2025, AND SEPTEMBER 4, 2025. BOTH DAYS IT WAS AT FACILITY A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2583934 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown