BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 22201439 · Received June 13, 2025

    Report

    Report Number
    2016493-2025-86958
    Event Type
    Malfunction
    Date Received
    June 13, 2025
    Date of Event
    May 20, 2025
    Report Date
    July 10, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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 AND D CODES AND MANUFACTURER NARRATIVE. INVESTIGATION SUMMARY: THE FACILITY REPORT REGARDING FAILURE TO ALARM IN THE PRESENCE OF AIR IN THE IV TUBING COULD NOT BE CONFIRMED DURING THE INVESTIGATION. NO DEVICES OR RECORDS WERE RETURNED FOR EVALUATION. THE INVESTIGATION COULD NOT INCLUDE EXTERNAL OR INTERNAL INSPECTIONS, SYSTEM LOG REVIEWS, OR LABORATORY TESTING DUE TO THE ABSENCE OF RETURNED DEVICES OR LOGS. HOWEVER, TWO PHOTOS OF THE IV TUBING INVOLVED WERE PROVIDED, REPORTEDLY SHOWING AIR PRESENT BELOW THE PUMP MODULE. ACCORDING TO THE AIR-IN-LINE ALARMS THE BD ALARIS¿ PUMP MODULE TIP SHEET, WHEN LOADING THE ADMINISTRATION SET INTO THE ALARIS¿ PUMP MODULE, THE TUBING SHOULD BE PUSHED FIRMLY TOWARD THE BACK OF THE AIR-IN-LINE DETECTOR. IF IT IS NOT INSERTED FAR ENOUGH, THE DETECTOR MAY SENSE AIR BEHIND THE TUBING AND TRIGGER AN ALARM. SOLUTIONS SHOULD BE ALLOWED TO WARM TO ROOM TEMPERATURE, IF POSSIBLE, AS AIR BUBBLES MAY FORM WHEN CHILLED SOLUTIONS BEGIN TO WARM. ACCORDING TO THE ALARIS SYSTEM USER MANUAL V12.5, IN ADDITION TO PROPER TUBING INSERTION, USERS SHOULD ENSURE THAT THE TUBING GUIDE ARM IS PRESENT AND FUNCTIONING, AS ITS ABSENCE CAN LEAD TO NUISANCE ALARMS. THE MANUAL ALSO REINFORCES THE IMPORTANCE OF WARMING COLD SOLUTIONS AND FOLLOWING BEST PRACTICES TO MINIMIZE AIR-IN-LINE RISKS. THERE WAS NO PATIENT HARM. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). ROOT CAUSE: THE ROOT CAUSE OF THE REPORTED ISSUE OF FAILURE TO ALARM IN THE PRESENCE OF AIR IN THE IV TUBING COULD NOT BE DETERMINED, AS NO DEVICES OR RECORDS WERE RETURNED FOR INVESTIGATION. HOWEVER, THE EVENT MAY BE RELATED TO IV SET LOADING OR TUBING POSITIONING. ACCORDING TO THE BD ALARIS SYSTEM USER MANUAL V12.5, PROPER INSERTION OF THE TUBING INTO THE AIR-IN-LINE DETECTOR IS ESSENTIAL FOR ACCURATE DETECTION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE HAD A PROPOFOL INFUSION (1,000MG PER 100ML IN A GLASS BOTTLE) THAT THE CLINICIAN HAD UNDERESTIMATED THE VTBI TO PREVENT AIR FROM GETTING INTO THE TUBING. THEY WENT IN THE PATIENT ROOM TO HANG A NEW BOTTLE OF PROPOFOL WITH A NEW IV SET (BD ALARIS PUMP INFUSION SET 2420-0007) AND NOTICED THAT THE DEVICE WAS NOT ALARMING AND AIR WAS NOTED IN THE IV TUBING BELOW THE PUMP MODULE. THIS WAS REPORTED TO BD REPRESENTATIVES DURING SITE VISIT. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE HAD A PROPOFOL INFUSION (1,000MG PER 100ML IN A GLASS BOTTLE) THAT THE CLINICIAN HAD UNDERESTIMATED THE VTBI TO PREVENT AIR FROM GETTING INTO THE TUBING. THEY WENT IN THE PATIENT ROOM TO HANG A NEW BOTTLE OF PROPOFOL WITH A NEW IV SET (BD ALARIS PUMP INFUSION SET 2420-0007) AND NOTICED THAT THE DEVICE WAS NOT ALARMING AND AIR WAS NOTED IN THE IV TUBING BELOW THE PUMP MODULE. THIS WAS REPORTED TO BD REPRESENTATIVES DURING SITE VISIT. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343939 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8015