BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSION PUMP

    MDR report key: 20999854 · Received December 23, 2024

    Report

    Report Number
    20999854
    Event Type
    Death
    Date Received
    December 23, 2024
    Date of Event
    December 6, 2024
    Report Date
    December 19, 2024
    Manufacturer
    BD
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PUMP CAUSED A RATE INCREASE FROM 2.5 MILLILITERS PER HOUR TO 25.6 MILLILITERS PER HOUR WITHOUT EXPLANATION. THIS PUMP WAS NEVER REMOVED ONCE THE INCIDENT WAS NOTICED. THIS PATIENT WAS EXTREMELY UNSTABLE, ON THE SAME PUMP WAS VERSED RUNNING AT 1 MILLILITER PER HOUR, LEVOPHED RUNNING AT 0.5 MILLILITERS PER HOUR (MAX) AND EPINEPHRINE AT 0.3 MILLILITERS PER HOUR (MAX), MAKING EXCHANGING THIS PUMP AT THIS TIME RISKY AND UNSAFE. IT WOULD ALSO REQUIRE US TO WASTE A NEAR-FULL BAGS OF VERSED AND FENTANYL (COSTLY TO THE PATIENT). AND UNSAFE FOR US TO LEAVE THE PATIENT TO WASTE THESE MEDICATIONS PROPERLY. AS WE WERE ARRANGING THE TRANSFER OF PUMPS, I NOTICED THAT THE FENTANYL AND VERSED WERE BOTH ATTACHED TO EXTENSION FILTER TUBING WITH PORTS INSTEAD OF THE PORT-LESS FILTER TUBING. THE PUMP WAS REMOVED FROM THE PATIENT¿S ROOM AND SENT FOR MAINTENANCE. MANUFACTURER RESPONSE FOR INFUSION PUMP, (BRAND NOT PROVIDED) (PER SITE REPORTER). NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88137 INFUSION PUMP PUMP, INFUSION FRN BD

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown Death