BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PUMP

    MDR report key: 16902656 · Received May 9, 2023

    Report

    Report Number
    MW5117407
    Event Type
    Death
    Date Received
    May 9, 2023
    Report Date
    May 9, 2023
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE ERROR THAT OCCURRED WAS A PUMP FAILURE. OUR HOSPITAL USES BD ALARIS PUMPS. THE PATIENT WAS ON NOREPINEPHRINE AND VASOPRESSIN DRIPS, IN ADDITION TO SEVERAL OTHER INTRAVENOUS MEDICATIONS. THE NURSE NOTICED A SIGNIFICANT DECREASE IN THE PATIENT'S BLOOD PRESSURE AND WENT TO ADJUST THE NOREPINEPHRINE DRIP. WHEN SHE TOUCHED THE CHANNEL THE NOREPINEPHRINE WAS RUNNING THROUGH, IT TURNED OFF, AS DID THE CHANNEL DELIVERING THE VASOPRESSIN. THE PATIENT CONTINUED TO DECOMPENSATE AND REQUIRED CPR. THE TEAM WAS ABLE TO GET NEW CHANNELS AND RESTART THE NOREPINEPHRINE AND VASOPRESSIN, BUT THE PATIENT ENDED UP EXPIRING. THE PUMP SCROLLED A BANNER THAT SAID COMMUNICATION ERROR" AT THE TIME OF THE MALFUNCTION. NURSES HAVE STATED THAT THERE HAVE BEEN OTHER OCCASIONS WHEN THEY RECEIVED "COMMUNICATION ERROR" BUT DID NOT REPORT THE PROBLEM. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217244 ALARIS PUMP PUMP, INFUSION FRN CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death NOREPINEPHRINE BITARTRATE| VASOPRESSIN INJECTION