BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 22976085 · Received September 5, 2025

    Report

    Report Number
    2016493-2025-111260
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    August 12, 2025
    Report Date
    May 11, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    UDI-DI
    10885403516047
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT LOGS HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED. 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

    CORRECTION: IT WAS DETERMINED THROUGH INVESTIGATION OF THE RETURNED DEVICES THAT THE INITIALLY REPORTED SUSPECT DEVICE REPORTED UNDER MANUFACTURER REPORT NUMBER IS A CONCOMITANT. THE DEVICE WAS AFFECTED DUE TO THE ISSUE OBSERVED ON THE SUSPECT DEVICE CAPTURED IN MANUFACTURER REPORT NUMBER 2016493-2025-111743.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN UNDER INFUSION OF CEFTAROLINE (CEFTAROLINE 5.92 MG IN NSS 0.5 ML IVPB). THE ELECTRONIC MEDICAL RECORD (EMR) RECORDED ADMINISTRATION OF CEFTAROLINE, HOWEVER THE PATIENT DID NOT ACTUALLY RECEIVE THE MEDICATION. THE RATE, DATE/TIME SEEN IN THE EMR UNDER CEFTAROLINE IS THE RATE, DATE/TIME FOR THE INFUSION OF BLOOD (TRANSFUSE RBC) 14 ML. THE EVENT OCCURRED BETWEEN 0500-0800. THE RATES RECORDED IN THE EMR FOR CEFTAROLINE WAS ACTUALLY THE RATE OF THE BLOOD ACCORDING TO THE NURSE. 0528 ¿ 5 ML/HOUR, 0530 3.73 ML/HOUR, 0532 ¿ 4.91 ML/HOUR, 0600 ¿ 4.91 ML/HOUR, 0800 ¿ 4.91 ML/HOUR, 0821 ¿ NEW BAG, 0823 ¿ 1.5 ML/HOUR. THE BLOOD INFUSION WAS PROGRAMMED MANUALLY, THEY DID SCAN CEFTRAOLINE BUT IT IS NOT BUILT IN THE NEONATAL DRUG LIBRARY. CEFTRAOLINE DID ASSOCIATE TO THE PUMP FROM NIGHT¿S DOSE THE DAY PRIOR TO THE EVENT. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN UNDER INFUSION OF CEFTAROLINE (CEFTAROLINE 5.92 MG IN NSS 0.5 ML IVPB). THE ELECTRONIC MEDICAL RECORD (EMR) RECORDED ADMINISTRATION OF CEFTAROLINE, HOWEVER THE PATIENT DID NOT ACTUALLY RECEIVE THE MEDICATION. THE RATE, DATE/TIME SEEN IN THE EMR UNDER CEFTAROLINE IS THE RATE, DATE/TIME FOR THE INFUSION OF BLOOD (TRANSFUSE RBC) 14 ML. THE EVENT OCCURRED BETWEEN 0500-0800. THE RATES RECORDED IN THE EMR FOR CEFTAROLINE WAS ACTUALLY THE RATE OF THE BLOOD ACCORDING TO THE NURSE. 0528 ¿ 5 ML/HOUR, 0530 3.73 ML/HOUR, 0532 ¿ 4.91 ML/HOUR, 0600 ¿ 4.91 ML/HOUR, 0800 ¿ 4.91 ML/HOUR, 0821 ¿ NEW BAG, 0823 ¿ 1.5 ML/HOUR. THE BLOOD INFUSION WAS PROGRAMMED MANUALLY, THEY DID SCAN CEFTRAOLINE BUT IT IS NOT BUILT IN THE NEONATAL DRUG LIBRARY. CEFTRAOLINE DID ASSOCIATE TO THE PUMP FROM NIGHT¿S DOSE THE DAY PRIOR TO THE EVENT. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192018 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION 303, INC. 8110 10885403516047

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown