BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 21822751 · Received April 10, 2025

    Report

    Report Number
    2016493-2025-72821
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    March 18, 2025
    Report Date
    July 9, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    MEA
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OMIT: B17 - DEVICE NOT RETURNED, C20 - NO FINDINGS AVAILABLE. ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL?, RETURNED TO MANUFACTURER ON, DEVICE EVAL BY MANUFACTURER?, IMDRF ANNEX A, G, B, C CODE 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 EVENT OF THE ¿PCA ERROR-UNKNOWN SYRINGE INSTALLED¿ WAS CONFIRMED THROUGH LABORATORY TESTING. LABORATORY TESTS WERE ABLE TO REPLICATE THE REPORTED EVENT OF NOT RECOGNIZING A BD 30ML SYRINGE. AN EXTERNAL AND INTERNAL INSPECTION WAS PERFORMED ON THE RETURNED SUSPECT PCA MODULES, AND NO ISSUES WERE FOUND THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. SYRINGE DETECTION TESTING WAS PERFORMED FOR ALL SUSPECT PCA MODULES AND THE REPORTED EVENT MENTIONED BY THE FACILITY WAS ABLE TO BE REPLICATED. A CALIBRATION TEST WAS PERFORMED FOR ALL PCA MODULES THROUGH ALARIS¿ SYSTEM MAINTENANCE (ASM) SO THAT THE SYRINGES COULD BE PROPERLY DETECTED ON THE DEVICE. ALL SUSPECT PCA MODULES POST CALIBRATION PASSED ALL PM (PREVENTIVE MAINTENANCE) TESTS IN ALARIS SYSTEM MAINTENANCE (ASM) (V12.5). SYRINGE RECOGNITION TESTS WERE PERFORMED ON ALL SUSPECTED PCA MODULES TO SEE IF THE ISSUE OF SYRINGE DETECTION FAILURE MENTIONED BY THE FACILITY NO LONGER PERSISTED, RESULTING IN THE RECOGNITION OF THE INSTALLED SYRINGES. A REVIEW OF THE LOGS WAS PERFORMED, AND NO RECORDS OF MALFUNCTIONS, ALARMS, OR ERRORS RELATED TO THE REPORTED ISSUE WERE OBSERVED. THE SUSPECT PCA MODULES WERE CONNECTED ON THE DATE PROVIDED BY THE FACILITY (18MAR2025) TO DIFFERENT PCU MODULES. PCA MODULE S/N 17070517 TO PCU MODULE S/N 16294788, PCA MODULE S/N 16993013 TO PCU MODULE S/N 16292725, PCA MODULE S/N 17070547 TO PCU MODULE S/N 16277985 AND PCA MODULE S/N 17070894 TO PCU MODULE S/N 16294788. ACCORDING TO SYRINGE LOADING ALARIS¿ PCA AND SYRINGE MODULES TIP SHEETS IT INDICATES THE FOLLOWING. STEP ONE¿OPEN THE SYRINGE BARREL CLAMP (CLEAR PIECE). STEP TWO¿RAISE THE DRIVE HEAD (GRAY IN COLOR) TO THE FULLY EXTENDED POSITION. STEP THREE¿LOAD THE SYRINGE. STEP FOUR¿LOCK THE SYRINGE IN PLACE. STEP FIVE¿LOWER THE DRIVE HEAD AND LOCK THE PLUNGER IN PLACE. THE SYSTEM WAS BEING USED FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). 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 FOR THE REPORTED ISSUE OF SYRINGE NOT RECOGNIZED COULD NOT BE DETERMINED, HOWEVER, DEVICE TESTING REPLICATED A SIMILAR EVENT IN WHICH THE BD 30 ML SYRINGE WAS NOT RECOGNIZED; THE ISSUE WAS RESOLVED THROUGH RECALIBRATION OF THE PCA MODULES. 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

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE PCA MODULE DOES NOT RECOGNIZE A BD 30 ML SYRINGE AND DISPLAYED THE ERROR MESSAGE AS "UNKNOWN SYRINGE INSTALLED AND RE-INSTALL SYRINGE". THIS OCCURRED DURING A TRAINING EXERCISE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE PCA MODULE DOES NOT RECOGNIZE A BD 30 ML SYRINGE AND DISPLAYED THE ERROR MESSAGE AS "UNKNOWN SYRINGE INSTALLED AND RE-INSTALL SYRINGE". THIS OCCURRED DURING A TRAINING EXERCISE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2440362 ALARIS SYSTEM PUMP, INFUSION MEA CAREFUSION SD 8120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown