BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAREFUSION 8015 ALARIS PUMP

    MDR report key: 9779684 · Received March 2, 2020

    Report

    Report Number
    MW5093471
    Event Type
    Death
    Date Received
    March 2, 2020
    Date of Event
    February 25, 2020
    Report Date
    February 27, 2020
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS RECEIVING LEVOPHED WHEN THE PUMP WAS BEEPING, SO RN PASSED IT. BP WAS 50/20S. PT'S CONDITION DETERIORATED AND PT SUBSEQUENTLY EXPIRED NEXT MORNING. UNK IF ISSUE WITH PUMP WAS DUE TO USER ERROR OR PUMP MALFUNCTION. BIOMED INSPECTED PUMP AND FOUND 9 MALFUNCTION ERRORS. NO ERRORS OR EVENTS DETERMINE THE BATTERY TO BE LOW OR ANY OTHER REASON FOR THE PUMP TO LEAD TO PT DEATH. A MALFUNCTION ALARM BEGAN ON (B)(6) 2020 AT 23:39. THEIR RECOMMENDATION WAS IN FUTURE TO ALWAYS KEEP THE LINES AND ACCESSORIES USED IN CASE THIS WAS THE CULPRIT SO APPARENTLY NOT ALL SUPPLIES KEPT BY STAFF. TRANSMIT ALARM CONTINUED TO SHOW MEANING IT MAY NOT HAVE BEEN TRANSMITTING APPROPRIATELY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239080 CAREFUSION 8015 ALARIS PUMP PUMP, INFUSION FRN CAREFUSION 303, INC. 8015

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death