BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 21501740 · Received March 3, 2025

    Report

    Report Number
    2016493-2025-63847
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Date of Event
    February 5, 2025
    Report Date
    September 4, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    MEA
    UDI-DI
    10885403516030
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OMIT: G07001 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. ADDITIONAL INFORMATION: IMDRF ANNEX G CODE AND MANUFACTURER NARRATIVE. 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: B21 - TYPE OF INVESTIGATION NOT YET DETERMINED, C21 - RESULTS PENDING COMPLETION OF INVESTIGATION, D16 - CONCLUSION NOT YET AVAILABLE. ADDITIONAL INFORMATION: DEVICE EVAL BY MANUFACTURER? , IMDRF ANNEX A,G,B,C,D CODES AND MANUFACTURER NARRATIVE. A DEVICE HISTORY RECORD, COMPLAINT HISTORY REVIEW, AND RISK REVIEW ON FAILURE MODES ARE PERFORMED ON EACH DEVICE WITH REPORTABLE MALFUNCTION(S) ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. INVESTIGATION SUMMARY: THE REPORTED COMPLAINT THAT THE PCA MODULE DISPLAYED AN UNKNOWN SYRINGE RE-INSTALL SYRINGE WAS NOT IDENTIFIED COULD NOT BE CONFIRMED OR REPLICATED DURING THIS INVESTIGATION. THE RETURNED DEVICE WAS FULLY EVALUATED, AND NO ANOMALIES WERE OBSERVED DURING THE PHYSICAL INSPECTION AND LABORATORY. ¿ SYRINGE RECOGNITION TESTS WERE PERFORMED ON THE SUSPECT PCA TRYING TO REPLICATE THE REPORTED ISSUE. THE TESTS CONCLUDED SUCCESSFULLY, WITH THE INSTALLED SYRINGES BEING RECOGNIZED. ¿ LABORATORY TESTING OF THE RETURNED PCA MODULE SHOWED THE DEVICE PASSING ALL ALARIS SYSTEM CALIBRATION AND MAINTENANCE TASKS. ¿ THE PCA MODULE LOGS WERE DOWNLOADED TO ASCERTAIN EVENT DETAILS ASSOCIATED TO THE REPORTED COMPLAINT. AFTER A REVIEW OF THE ERROR LOGS, NO RECORDS WERE FOUND THAT CONTRIBUTED TO THE REPORTED ISSUE. ¿ ACCORDING TO THE ALARIS¿ SYSTEM USER MANUAL (V12.3.1) STATES THAT AN INSTRUMENTS ARE TESTED AND CALIBRATED BEFORE THEY ARE PACKAGED FOR SHIPMENT. TO ENSURE PROPER OPERATION AFTER SHIPMENT, IT IS RECOMMENDED THAT AN INCOMING INSPECTION BE PERFORMED BEFORE PLACING THE INSTRUMENT IN USE. ¿ SYRINGE LOADING ALARIS¿ PCA AND SYRINGE MODULES TIP SHEET STATES: O IF THE INSTALLED SYRINGE IS LOADED CORRECTLY BUT NOT RECOGNIZED, CHECK FOR THE FOLLOWING: IF A LABEL IS BETWEEN THE SYRINGE BARREL AND THE BARREL CLAMP, MAKE SURE THAT IT DOES NOT ERRONEOUSLY ENLARGE THE BARREL SIZE OF THE SYRINGE. IF A NEEDLE-FREE VALVE OR OTHER COMPONENT IS ADDED TO THE SYRINGE, ENSURE THAT IT IS NO LARGER THAN THE DIAMETER OF THE SYRINGE BARREL. NOTE TO REPAIR CENTER: DEVICE WAS DISASSEMBLED FOR THIS INVESTIGATION, PLEASE ENSURE PROPER ASSEMBLY, TORQUING OF SCREWS, AND APPROPRIATE TESTING IS PERFORMED. REPAIR CENTER SHOULD FOLLOW THEIR NORMAL PROCESSING OF THE DEVICE, LOOKING FOR ANY INCIDENTAL ISSUES PRIOR TO RETURNING IT TO THE CUSTOMER. DCHU WILL NOT BE PICKING UP THE COST OF THE INCIDENTAL REPAIRS. ROOT CAUSE: THE ROOT CAUSE OF THE REPORTED THAT THE PCA MODULE DISPLAYED AN UNKNOWN SYRINGE RE-INSTALL SYRINGE WAS NOT IDENTIFIED. NO ISSUES WERE OBSERVED WITH THE RECEIVED PCA MODULE DURING INSPECTION AND TESTING PROCESS.

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING STAFF CLASSROOM EDUCATION PROVIDED BY BD REPRESENTATIVE, THE PCA MODULE DISPLAYED "AN UNKNOWN SYRINGE, RE-INSTALL SYRINGE" MESSAGE UPON LOADING A BD 30ML SYRINGE THAT WAS SUPPLIED BY BD REPRESENTATIVE. PER REPORT, A BD 30ML SYRINGE (REF (B)(4), LOT 4122461) WAS LOADED INTO THE PCA MODULE WHEN IT GAVE OFF THE "UNKNOWN SYRINGE INSTALLED" MESSAGE. BD REPRESENTATIVE THEN TESTED THE SAME PCA MODULE WITH BD 20ML SYRINGE FROM THE FACILITY'S CURRENT SUPPLY STOCK. WHEN THE BD 20ML SYRINGE REF (B)(4), LOT 4197114 WAS LOADED INTO THE PCA MODULE, IT HAD NO ISSUES. THE 20ML SYRINGE WAS THEN REMOVED FROM THE PCA MODULE AND INSERTED THE 30ML SYRINGE USED PREVIOUSLY DURING STAFF EDUCATION. IT REPORTEDLY "WORKED FINE FOR PROGRAMMING." HOWEVER, THE BD REPRESENTATIVE POWERED OFF THE PCU, DETACHED THE MODULE, AND THEN TURN THE PCU BACK ON AND ATTACH THE PCA MODULE. AFTER DOING THIS, THE SAME 30ML SYRINGE WAS LOADED AND IT AGAIN GAVE THE ERROR MESSAGE AGAIN AS PREVIOUSLY STATED. THE 30ML SYRINGE WAS LEFT INSIDE OF THE PCA MODULE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING STAFF CLASSROOM EDUCATION PROVIDED BY BD REPRESENTATIVE, THE PCA MODULE DISPLAYED "AN UNKNOWN SYRINGE, RE-INSTALL SYRINGE" MESSAGE UPON LOADING A BD 30ML SYRINGE THAT WAS SUPPLIED BY BD REPRESENTATIVE. PER REPORT, A BD 30ML SYRINGE ((B)(4), LOT 4122461) WAS LOADED INTO THE PCA MODULE WHEN IT GAVE OFF THE "UNKNOWN SYRINGE INSTALLED" MESSAGE. BD REPRESENTATIVE THEN TESTED THE SAME PCA MODULE WITH BD 20ML SYRINGE FROM THE FACILITY'S CURRENT SUPPLY STOCK. WHEN THE BD 20ML SYRINGE REF (B)(4), LOT 4197114 WAS LOADED INTO THE PCA MODULE, IT HAD NO ISSUES. THE 20ML SYRINGE WAS THEN REMOVED FROM THE PCA MODULE AND INSERTED THE 30ML SYRINGE USED PREVIOUSLY DURING STAFF EDUCATION. IT REPORTEDLY "WORKED FINE FOR PROGRAMMING." HOWEVER, THE BD REPRESENTATIVE POWERED OFF THE PCU, DETACHED THE MODULE, AND THEN TURN THE PCU BACK ON AND ATTACH THE PCA MODULE. AFTER DOING THIS, THE SAME 30ML SYRINGE WAS LOADED AND IT AGAIN GAVE THE ERROR MESSAGE AGAIN AS PREVIOUSLY STATED. THE 30ML SYRINGE WAS LEFT INSIDE OF THE PCA MODULE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING STAFF CLASSROOM EDUCATION PROVIDED BY BD REPRESENTATIVE, THE PCA MODULE DISPLAYED "AN UNKNOWN SYRINGE, RE-INSTALL SYRINGE" MESSAGE UPON LOADING A BD 30ML SYRINGE THAT WAS SUPPLIED BY BD REPRESENTATIVE. PER REPORT, A BD 30ML SYRINGE (B)(4), LOT 4122461) WAS LOADED INTO THE PCA MODULE WHEN IT GAVE OFF THE "UNKNOWN SYRINGE INSTALLED" MESSAGE. BD REPRESENTATIVE THEN TESTED THE SAME PCA MODULE WITH BD 20ML SYRINGE FROM THE FACILITY'S CURRENT SUPPLY STOCK. WHEN THE BD 20ML SYRINGE REF 303310, LOT 4197114 WAS LOADED INTO THE PCA MODULE, IT HAD NO ISSUES. THE 20ML SYRINGE WAS THEN REMOVED FROM THE PCA MODULE AND INSERTED THE 30ML SYRINGE USED PREVIOUSLY DURING STAFF EDUCATION. IT REPORTEDLY "WORKED FINE FOR PROGRAMMING." HOWEVER, THE BD REPRESENTATIVE POWERED OFF THE PCU, DETACHED THE MODULE, AND THEN TURN THE PCU BACK ON AND ATTACH THE PCA MODULE. AFTER DOING THIS, THE SAME 30ML SYRINGE WAS LOADED AND IT AGAIN GAVE THE ERROR MESSAGE AGAIN AS PREVIOUSLY STATED. THE 30ML SYRINGE WAS LEFT INSIDE OF THE PCA MODULE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777230 ALARIS SYSTEM PUMP, INFUSION MEA CAREFUSION SD 8120 10885403516030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8015