BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOJCT 20ML SYR L-LOCK

    MDR report key: 17690635 · Received September 6, 2023

    Report

    Report Number
    1282497-2023-10784
    Event Type
    Injury
    Date Received
    September 6, 2023
    Date of Event
    August 25, 2023
    Report Date
    February 12, 2024
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FMF
    UDI-DI
    10884521010802
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 MEDICAL DEVICE PROBLEM CODE WAS UPDATED.

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE HAS BEEN CONFIRMED AND A CAPA-CRP-03163 HAS BEEN INITIATED TO FURTHER INVESTIGATE. IN ADDITION, THE REPORTED DEVICE IS PART OF A RECALL, EVENT-2023-05729/RES 93075. PLEASE REFER TO THE RECALL FOR ADDITIONAL DETAILS.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056928 MONOJCT 20ML SYR L-LOCK SYRINGE, PISTON FMF CARDINAL HEALTH 1182000777 10884521010802

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other