BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 20479745 · Received October 18, 2024

    Report

    Report Number
    2016493-2024-39042
    Event Type
    Malfunction
    Date Received
    October 18, 2024
    Date of Event
    September 24, 2024
    Report Date
    November 25, 2024
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 0

    OMIT : C20 - NO FINDINGS AVAILABLE, D15 - CAUSE NOT ESTABLISHED. ADDITIONAL INFORMATION : IMDRF ANNEX A, G, B, C, D CODES AND MANUFACTURER NARRATIVE. INVESTIGATION SUMMARY : THE REPORTED COMPLAINT OF AN INACCURATE DELIVERY OF MILRINONE COULD NOT BE CONFIRMED. ¿ NO DEVICE WAS PROVIDED BY THE FACILITY FOR FURTHER ANALYSIS. ¿ A LOG ANALYSIS WAS NOT ABLE TO BE PERFORMED AS THERE WERE NO DEVICES OR LOGS RETURNED FOR INVESTIGATION. ¿ THE PHOTO OF THE PCU SCREEN AND SYRINGE MODULE OFFERED NO INFORMATION FOR INVESTIGATION OF THE REPORTED ISSUE. THE PHOTO NOTED THE DOSE (0.05 MG/KG/H) WAS LESS THAN WHAT WAS THE INTENDED ORDER OF 0.5 MG/KG/H. ¿ THE BD ALARISTM GUARDRAILS EDITOR V12.1 GUARDRAILSTM SUITE MX. SOFTWARE USER MANUAL NOTES THAT INFUSION PARAMETERS ARE TO BE VERIFIED BEFORE SELECTING THE START KEY. ¿ THE DEVICES WERE REPORTED TO HAVE BEEN IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED ISSUE OF AN INACCURATE DELIVERY OF MILRINONE COULD NOT BE IDENTIFIED BECAUSE THE REQUESTED DEVICES OR THEIR ASSOCIATED LOGS AND DATA SET WERE NOT PROVIDED BY THE FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN YEAR OLD PATIENT OF 12.9 KG WEIGHT WAS ORDERED WITH MILRINONE INFUSION WHICH WAS INITIALLY RUNNING AT 0.5 MG/KG/HR (0.97ML/HR), HOWEVER AFTER ERROR, THE DOSE WAS CHANGED TO 1.1ML/HR WHICH IS APPROXIMATELY 0.5685MG/KG/HR. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN YEAR OLD PATIENT OF 12.9 KG WEIGHT WAS ORDERED WITH MILRINONE INFUSION WHICH WAS INITIALLY RUNNING AT 0.5 MG/KG/HR (0.97ML/HR), HOWEVER AFTER ERROR, THE DOSE WAS CHANGED TO 1.1ML/HR WHICH IS APPROXIMATELY 0.5685MG/KG/HR. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1716998 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8110

    Patients

    Seq Age Sex Outcome Treatment
    1 21 MO Unknown