BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 24206899 · Received January 29, 2026

    Report

    Report Number
    2016493-2026-02788
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Date of Event
    December 10, 2025
    Report Date
    February 16, 2026
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DATE OF EVENT IS UNKNOWN. 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. CORRECTION: DESCRIBE EVENT OR PROBLEM. ADDITIONAL INFORMATION: IMDRF ANNEX A, B, C, D, G CODES AND MANUFACTURER NARRATIVE. INVESTIGATION SUMMARY: THE REPORTED ISSUE ABOUT THE SYRINGE MODULE MISREADING BD 3 ML SYRINGES AS 10 ML WAS IDENTIFIED AS THE USE OF A NON-BD APPROVED, INCOMPATIBLE SYRINGE. THERE WERE NO DEVICES RETURNED FOR INVESTIGATION. THE FACILITY MADE A PRODUCT ENHANCEMENT REQUEST TO HAVE THE APPROVAL OF PREFILLED SALINE FLUSHES AND MORPHINE IMS NDC: 76329-1912-01 SYRINGES. THIS REQUEST HAS BEEN FORWARDED TO BD MARKETING FOR REVIEW AND PRODUCT ENHANCEMENT REQUEST (PER) DETERMINATION UNDER PER 2726. NO LABORATORY TESTING WAS ABLE TO BE PERFORMED ON THE REPORTED DEVICE AS IT WAS NOT RETURNED FOR INVESTIGATION. THE EXTERNAL AND INTERNAL INSPECTION COULD NOT BE PERFORMED AS THE SUSPECT DEVICES WERE NOT RECEIVED FOR INVESTIGATION. THE FACILITY PROVIDED A DESCRIPTION AND PHOTOS OF THE EVENT ISSUE. THE FACILITY REPORTED A SYRINGE MODULE IS MISREADING BD 3 ML SYRINGES AS 10 ML, HOWEVER, THE CUSTOMER IS USING SYRINGES NOT AUTHORIZED BY BD, AS CAN BE SEEN PHOTOS PROVIDED. THE IMAGE SHOWS THE START OF AN INFUSION PROGRAM WHERE A 5 ML SYRINGE IS LOADED INTO THE MODULE, AND THE PCU READS THAT IT CONTAINS A VOLUME OF 4.09 ML AVAILABLE FOR DELIVERY; THE SCREEN ALSO DISPLAYS A RECORD FOR A BD 10 ML SYRINGE. THIS PROBABLE ERROR IN THE SYRINGE VOLUME READING IS DUE TO THE USE OF SYRINGES NOT COMPATIBLE WITH THE SYRINGE MODULE. THE BD ALARIS USER MANUAL V12.3.2 STATES DO NOT USE INCOMPATIBLE SYRINGE SIZES AND MODELS WITH THE SYRINGE MODULE. USE OF INCOMPATIBLE SYRINGES CAN IMPACT PUMP OPERATION RESULTING IN INACCURATE FLUID DELIVERY, DELAYED GENERATION OF OCCLUSION ALARMS, AND OTHER POTENTIAL PROBLEMS, WHICH ARE OF PARTICULAR IMPORTANCE FOR NEONATAL POPULATIONS, INCLUDING LOW, VERY LOW, AND EXTREMELY LOW BIRTHWEIGHT NEONATES. THE SYRINGE MODULE IS CALIBRATED AND LABELED FOR USE WITH THE SYRINGE MODELS LISTED IN THE TABLE. USE ONLY THE SYRINGE SIZE AND TYPE SPECIFIED ON THE MAIN DISPLAY. MEDICATIONS DELIVERED ON THE SYRINGE MODULE MUST BE PREPARED IN A SYRINGE THAT ACCOMMODATES THE DESIRED FLOW RATE. THE LIST OF COMPATIBLE SYRINGES CAN ALSO BE LOCATED ON THE BD WEBSITE WHERE YOU CAN DOWNLOAD. THE SYSTEM WAS BEING USED FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). ROOT CAUSE: THE ROOT CAUSE OF THE SYRINGE MODULE MISREADING BD 3 ML SYRINGES AS 10 ML WAS ATTRIBUTABLE TO THE USE OF A NON-BD, THIRD-PARTY SYRINGE. THERE WERE NO DEVICES RETURNED FOR INVESTIGATION. 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 BY THE CUSTOMER THAT THERE WAS A PRODUCT ENHANCEMENT REQUEST RELATED TO PREFILLED SYRINGES. THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER HAS MADE A PRODUCT ENHANCEMENT REQUEST TO HAVE THE FOLLOWING: 1. APPROVAL OF PREFILLED SALINE FLUSHES. 2. MORPHINE IMS NDC: 76329-1912-01 SYRINGES, THE CUSTOMER WOULD LIKE TO HAVE THESE SYRINGES APPROVED ALSO. THE PACKAGE INSERTS STATES THAT IT IS ALARIS APPROVED, HOWEVER. IT IS NOT ON THE SYRINGE COMPATIBILITY LIST. FURTHER INFORMATION WAS RECEIVED BY THE CUSTOMER ON 05JAN2026 WHICH REPORTS THAT THE PUMP IS READING THE BD 3ML SYRINGE AS A 10ML SYRINGE. THE CUSTOMER IS USING 3ML PRE-FILLED SYRINGES THAT ARE NOT CURRENTLY ON THE COMPATIBILITY LIST.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A PRODUCT ENHANCEMENT REQUEST RELATED TO PREFILLED SYRINGES. THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER HAS MADE A PRODUCT ENHANCEMENT REQUEST TO HAVE THE APPROVAL OF PREFILLED SALINE FLUSHES AND MORPHINE IMS NDC: 76329-1912-01 SYRINGES, THE PACKAGE INSERTS STATES THAT IT IS ALARIS APPROVED, HOWEVER. IT IS NOT ON THE SYRINGE COMPATIBILITY LIST. FURTHER INFORMATION WAS RECEIVED BY THE CUSTOMER ON 05JAN2026 WHICH REPORTS THAT THE PUMP IS READING THE BD 3ML SYRINGE AS A 10ML SYRINGE. THE CUSTOMER IS USING 3ML PRE-FILLED SYRINGES THAT ARE NOT CURRENTLY ON THE COMPATIBILITY LIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340719 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8015.