BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 18408543 · Received December 28, 2023

    Report

    Report Number
    2016493-2023-252344
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Date of Event
    August 25, 2023
    Report Date
    December 18, 2023
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. H3 OTHER TEXT : DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.

    Description of Event or Problem · 0

    BD PROACTIVELY OBTAINED THE REPORT IN THE MAUDE DATABASE, WHICH STATES ¿THE CUSTOMER REPORTED THEY ARE USING THE CARDINAL HEALTH (CAH) BRAND SYRINGES IN THE ALARIS INFUSION PUMP AND EXPERIENCING MEDICATION DELIVERING FASTER THAN IT SHOULD. FOR EXAMPLE, IF THE PUMP IS SET TO INFUSE OVER 13 HOURS, IT IS DELIVERING MEDICATION IN 6-7 HOURS AS IT IS DETECTING INCORRECT VOLUMES IN THE PUMPS. EXAMPLE: THE PUMP IS DETECTING A VOLUME OF 7, BUT THERE IS ONLY A VOLUME OF 5, SO IT IS ADMINISTERING FASTER THAN SET AS THE PUMP BELIEVES THERE IS MORE MEDICATION TO DELIVER OVER THE PERIOD OF TIME. THIS HAS LED TO PATIENTS RECEIVING "LIFE SUSTAINING" MEDICATION TOO QUICKLY. THE CUSTOMER STATED THE PHARMACY DID THEIR OWN TESTING USING WATER IN THE CAH BRAND 3ML, 6ML, 20ML AND 35ML SYRINGES IN THE ALARIS PUMP AND EACH TIME THE PUMP DETECTED INCORRECT VOLUME, STATING 100% FAILURE RATE. THE HOSPITAL IS PULLING ALL CAH BRAND SYRINGES FROM THE FLOORS, STARTING WITH CRITICAL AREAS, AND WILL SEQUESTER PRODUCT FOR INVESTIGATION SAMPLES.¿ ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED. REPORT NUMBERS: 1282497-2023-10778, 1282497-2023-10779, 1282497-2023-10780, 1282497-2023-10781, 1282497-2023-10782, 1282497-2023-10783, 1282497-2023-10784, 1282497-2023-10785, 1282497-2023-10786, 1282497-2023-10787, 1282497-2023-10788.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1529759 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8110

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 8015