BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVUM IQ

    MDR report key: 21911443 · Received April 25, 2025

    Report

    Report Number
    1416980-2025-02493
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    March 28, 2025
    Report Date
    October 30, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    05413765852428
    PMA / PMN Number
    K242390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H3, H6, H11. H11: A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. A REVIEW OF THE EVENT HISTORY LOGS DID NOT CONTAIN ANY EVENTS FROM THE DATE OF THE REPORTED ISSUE. THE INFUSION DATA WAS INVESTIGATED FROM THE IQE FILE. THERE WERE TWO ROWS OF INFUSION DATA FOUND WITH TIMESTAMP 2025-03-28 09:05:55+00 AND 2025-03-28 09:12:16+00. 1. DATA LOGGED AT 2025-03-28 09:05:55+00 - THIS IQE LOG DATA INCLUDED ELAPSED TIME 185 SECONDS, REMAINING TIME 115 WITH INFUSED VOLUME 1.0883 ML AND REMAINING VOLUME 0.6718 CORRESPONDS CORRECTLY TO MAIN INFUSION OF 176 MG. IT ALSO INCLUDED A TOTAL CALCULATED TIME OF 300 SECONDS AND FLOW RATE AS 21.12 ML/HR. IN NEXT 115 SECONDS THIS INFUSION WOULD COMPLETE. NOTE THE DELIVERY_STATUS: NOMINAL INDICATED THAT THIS INFORMATION BELONGS TO THE MAIN INFUSION. 2. DATA LOGGED AT 2025-03-28 09:12:16+00 - THIS IQE LOG INDICATED THE MAIN INFUSION WAS ALREADY OVER BY THIS TIME (AS MORE THAN 115 SECONDS FROM PREVIOUS DATA HAD ALREADY PASSED). NOTE THE DELIVERY_STATUS: LINEFLUSH INDICATED THAT THE SYRINGE WAS FLUSHED USING LINE FLUSH OPERATION IMMEDIATELY UPON THE MAIN INFUSION COMPLETION. THE DATA SHOWED THE LINE FLUSH WAS SET WITH THE FLOW RATE OF 21.12 ML/HR (SAME AS THE PREVIOUS MAIN INFUSION) AND PROGRAMMED VTBI AS 2 ML. THE SYRINGE PUMP USUALLY OFFERS LINE FLUSH OPTION TO THE CLINICIAN UPON MAIN INFUSION COMPLETION, THE LINE FLUSH SETUP CONFIRMS FROM THE CLINICIAN IF THEY WANT LINE FLUSH TO BE DELIVERED AT THE SAME RATE AS THE PREVIOUS MAIN INFUSION. IF CONFIRMED, THE MAIN INFUSION RATE IS APPLIED TO LINE FLUSH. THE LINE FLUSH SETUP SCREEN ALSO ALLOWS THE CLINICIAN TO ENTER A VTBI VALUE. THE IQE FILE INDICATED THAT THE LINE FLUSH WAS PROGRAMED WITH 21.12 ML/HR (SAME AS PREVIOUS MAIN INFUSION) AND VTBI OF 2 ML. THE FLUSH AND MAIN INFUSION SETUP AND RUNNING SCREEN LAYOUT ARE SIMILAR WITH THE DIFFERENCE IN THE LABEL INDICATING THE TYPE OF INFUSION. THE LINE FLUSH SETUP SCREEN USES LABEL ¿LINE FLUSH¿ AT THE TOP CENTER OF THE SCREEN WHILE THE LINE FLUSH RUNNING SCREEN USES LABEL ¿LINE FLUSH¿ AT THE BOTTOM CENTER OF THE SCREEN. AS PER THE COMPLAINT DESCRIPTION, THE CLINICIAN WAS UNABLE TO PROVIDE WHAT WAS ON THE SCREEN. THIS SCREEN COULD BE FLUSH SETUP SCREEN RESPONSIBLE FOR 2 ML DELIVERY. IN SUMMARY, THE IQE DATA INDICATED THAT THE FLUSH INFUSION WAS GIVEN WITH 2 ML VTBI AT THE SAME RATE AS THE MAIN INFUSION. HENCE THE SYRINGE WAS EMPTY AFTER THE COMPLETION OF INFUSION, DELIVERING ALL 2 ML OF MEDICATION. IT APPEARS THE PUMP IS BEHAVING AS EXPECTED HOWEVER THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NOVUM IQ SYRINGE PUMP OVER-INFUSED ANTIBIOTIC DURING PATIENT INFUSION. AMPICILLIN (2ML) WAS DRAWN UP IN A 5ML NON-BAXTER SYRINGE. THE CLINICIAN PRIMED THE SYRINGE TUBING WITH SALINE. THE AMOUNT/TIME WAS 100MG, VOLUME TO BE INFUSED (VTBI) 1.75ML, AND 176MG DOSE. AT THE COMPLETION, THE INFUSION SYRINGE WAS EMPTY DELIVERING ALL 2ML OF MEDICATION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755106 NOVUM IQ PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION 40800BAXUS NA 05413765852428

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown AMPICILLIN| BD SYRINGE| SALINE