BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 21906227 · Received April 25, 2025

    Report

    Report Number
    2016493-2025-76020
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    March 31, 2025
    Report Date
    June 24, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403222054
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-2718-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DATE OF EVENT IS UNKNOWN. 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.

    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 REPORT OF AN OVER INFUSION WAS NOT CONFIRMED THROUGH A REVIEW OF THE LOGS OR REPRODUCED DURING LABORATORY TESTING RATE ACCURACY TESTING WAS PERFORMED ON THE SUSPECT PUMP MODULE. THE DEVICE WAS FOUND TO BE OPERATING WITHIN SPECIFICATION. LOG REVIEW OF THE INVOLVED DEVICES WAS ABLE TO IDENTIFY THE PUMP MODULE S/N (B)(6) AS THE SUSPECT PUMP MODULE SINCE THE REPORTED PARAMETERS WERE PROGRAMMED ON THE MODULE NEAR TO THE REPORTED EVENT DATE. EVENT LOG REVIEW SHOWED NO RECORD OF USAGE DURING THE REPORTED EVENT DATE; HOWEVER, ON 27 MARCH 2025 AT 12:02 PM THE CONCOMITANT PCU S/N (B)(6) WAS POWERED ON, AND THE SUSPECT PUMP MODULE S/N (B)(6) WAS ATTACHED AS CHANNEL B. AT 12:03:52 PM AN INFUSION OF ACETAMINOPHEN STARTED ON THE SUSPECT PUMP MODULE WITH A RATE OF 400 ML/H AND VTBI OF 100 ML, WITH AN EXPECTED DURATION OF 15 MINUTES. ACCORDING TO THE EVENT LOG REVIEW BETWEEN 12:20 TO 12:22 PM THE REPORTED INFUSION OF POTASSIUM CHLORIDE WAS PROGRAMMED AND STARTED WITH VTBI OF 50ML AND RATE OF 50ML/H WITH AN ESTIMATED DURATION OF 1 HOUR. AT 12:32 PM THE PUMP ALARMED FOR OCCLUSION AND THE INFUSION WAS RESTARTED. AT 12:38 PM THE USER PAUSED THE INFUSION, BETWEEN 12:41 PM TO 12:48 PM THE INFUSION WAS RESTARTED AND PAUSED AGAIN AFTER A FEW MINUTES THE UNIT WAS REMOVED, THEREFORE THE INFUSION WAS NOT COMPLETED. THE ALARIS SYSTEM USER MANUAL (V12.3), STATES WITHIN WARNINGS AND CAUTIONS, ¿TO PREVENT A POTENTIAL FREE-FLOW CONDITION, ENSURE THAT NO EXTRANEOUS OBJECT (FOR EXAMPLE, BEDDING, TUBING, GLOVE) IS ENCLOSED OR CAUGHT IN THE PUMP MODULE DOOR.¿ IT IS NOT POSSIBLE TO DETERMINE WHAT THE ACTUAL VOLUME IS WITHIN AN IV CONTAINER AT THE START AND ENDING OF AN INFUSION FROM A REVIEW OF THE PCU EVENT LOG. IT IS ALSO NOT POSSIBLE TO DETERMINE WHAT THE FLUID IS THAT IS CONTAINED WITHIN THE IV CONTAINER. THIS IS NOT A FUNCTION OF THE PCU EVENT LOG; IT ONLY CAN REFLECT THE INPUTTED INFORMATION IT RECEIVES EITHER MANUALLY OR REMOTELY WITH RESPECT TO VOLUME TO BE DELIVERED AND FLUID SELECTED. THE ALARIS SYSTEM USER MANUAL, DOOR KEYPAD ARTWORK, AND THE QUICK REFERENCE GUIDE REMIND THE USER TO ¿CLOSE THE ROLLER CLAMP BEFORE OPENING THE DOOR¿. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). THE PUMPING MECHANISM WAS DISASSEMBLED DURING THE INTERNAL INSPECTION. THE MECHANISM ASSEMBLIES CANNOT BE REASSEMBLED SINCE MANUFACTURING PERFORMS SEVERAL TESTS NOT AVAILABLE TO DESIGNATED COMPLAINT HANDLING UNIT (DCHU), REPAIR CENTER OR THE CUSTOMER. NOTE TO REPAIR CENTER: DEVICE OPENED FOR INVESTIGATION, PLEASE RE-TORQUE ALL SCREWS. PLEASE REPLACE THE MECHANISM ASSEMBLY AS IT WAS DISASSEMBLED DURING THE INVESTIGATION. MECHANISM ASSEMBLIES CANNOT BE REASSEMBLED SINCE MANUFACTURING PERFORMS SEVERAL TESTS NOT AVAILABLE TO DESIGNATED COMPLAINT HANDLING UNIT (DCHU), REPAIR CENTER OR THE CUSTOMER. THIS MAY BE CHARGED TO DCHU. 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 AN OVER INFUSION EVENT WAS NOT ABLE TO BE IDENTIFIED. THE PUMP MODULE WAS FOUND TO BE INFUSING WITHIN SPECIFICATION, THE RETURNED DEVICE WAS FULLY EVALUATED, AND NO ANOMALIES WERE FOUND DURING LABORATORY TESTING. LOG REVIEW SHOWED THE USER REMOVED THE UNIT BEFORE THE INFUSION WAS ABLE TO BE COMPLETED. NOTE THAT THIS REPORT LISTS IMDRF ANNEX C0601, D15, A1801, G04037, G02017, D01 CODES NOT ASSOCIATED WITH THE REPORTED EVENT BUT IDENTIFIED AS REPORTABLE MALFUNCTIONS OBSERVED ON THE DEVICE DURING INVESTIGATION ARE UNRELATED TO THE REPORTED ISSUE. THESE OTHER FAILURES PRESUMPTIVELY DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE. 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 CUSTOMER "1 BAG OF IV POTASSIUM WAS STARTED AT 1220 FOR THIS PATIENT BY RN. CHANNEL WAS PROGRAMMED AT ORDERED RATE OF5 50ML/HR. BAG WOULD RUN OVER 1 HOUR. STARTED INFUSION AND LEFT ROOM. HEARD IV PUMP ALARMING AT 1248. NOTED CHANNEL RUNNING POTASSIUM WAS ALARMING. NOTED AIR IN LINE ALARM. NOTED POTASSIUM BAG TO BE COMPLETELY EMPTY. PAUSED INFUSION AND CHECKED FOR CONFIRMATION THAT PUMP WAS PROGRAMMED CORRECTLY BY RN. IT WAS VERIFIED THAT THE PUMP WAS PROGRAMMED CORRECTLY. THE PATIENT WAS NOT INJURED. CUSTOMER IS REQUESTING A WRITTEN REPORT. CUSTOMER REPORT: (B)(4)". THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER "1 BAG OF IV POTASSIUM WAS STARTED AT 1220 FOR THIS PATIENT BY RN. CHANNEL WAS PROGRAMMED AT ORDERED RATE OF5 50ML/HR. BAG WOULD RUN OVER 1 HOUR. STARTED INFUSION AND LEFT ROOM. HEARD IV PUMP ALARMING AT 1248. NOTED CHANNEL RUNNING POTASSIUM WAS ALARMING. NOTED AIR IN LINE ALARM. NOTED POTASSIUM BAG TO BE COMPLETELY EMPTY. PAUSED INFUSION AND CHECKED FOR CONFIRMATION THAT PUMP WAS PROGRAMMED CORRECTLY BY RN. IT WAS VERIFIED THAT THE PUMP WAS PROGRAMMED CORRECTLY. THE PATIENT WAS NOT INJURED. CUSTOMER IS REQUESTING A WRITTEN REPORT. CUSTOMER REPORT: SL-170348". THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502048 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403222054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown