BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 20266074 · Received September 20, 2024

    Report

    Report Number
    2016493-2024-36996
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Date of Event
    August 19, 2024
    Report Date
    November 21, 2024
    Manufacturer
    CAREFUSION SD
    Product Code
    CCK
    UDI-DI
    10885403830013
    PMA / PMN Number
    K031741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OMIT : B17 - DEVICE NOT RETURNED, C20 - NO FINDINGS AVAILABLE CORRECTION: DATE OF EVENT ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL?, RETURNED TO MANUFACTURER ON, DEVICE EVAL BY MANUFACTURER?, IMDRF ANNEX A, B, C, D, G 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. THE ACTUAL DATE OF EVENT IS UNKNOWN. INVESTIGATION SUMMARY: THE REPORTED ERROR CODE 571.6241 (OEM MISSING SENSOR STATUS) WAS CONFIRMED AND IDENTIFIED. ¿ EXTERNAL INSPECTION ON THE ¿AS RECEIVED¿ THIRTEEN (13) ETCO2 MODULES DID NOT FOUND ANY THIRD-PARTY PART OR MALFUNCTION RELATED TO THE REPORTED ERROR. ¿ THE SUSPECT ETCO2 MODULES (4) SN¿S:(B)(6) IN THE ¿AS-RECEIVED¿ CONDITION WERE ATTACHED TO A KNOWN GOOD LABORATORY AND THE PCU ALARMED CHANNEL ERROR 570.6200. ¿ THE SUSPECT ETCO2 MODULE SN: (B)(6) IN THE ¿AS-RECEIVED¿ CONDITION WERE ATTACHED TO A KNOWN GOOD LABORATORY PCU ALARMED CHANNEL ERROR 571.6241. O AFTER INSPECTION, FOR THE SN¿S:(B)(6) ORIDION BOARD WAS REPLACED BY A KNOWN GOOD PART, WHICH ELIMINATED THE ERROR. ¿ THE REVIEW OF EVENT AND ERROR LOGS FOR THE SUSPECT ETCO2 MODULES IDENTIFIED THE FOLLOWING CONDITIONS: O SN: (B)(6) THE REVIEW OF THE SUSPECT ETCO2 ERROR LOG DID NOT IDENTIFY ERROR CODES. THE EVENT LOG SHOWS A MALFUNCTION DUE TO SOFTWARE COMPATIBILITY. O SN: 1(B)(6) THE REVIEW OF THE SUSPECT ETCO2 ERROR LOGS IDENTIFIED MULTIPLE 570.6200.0 ERROR CODES OCCURRING BETWEEN (B)(6) 2024. O SN: (B)(6) THE REVIEW OF THE SUSPECT ETCO2 ERROR LOG IDENTIFIED THE ERROR CODE 570.6200.0 EIGHT (8) TIMES LAST ONE REGISTERED ON 12-APR-2024 11:42:38 AM. O SN: (B)(6) THE REVIEW OF THE SUSPECT ETCO2 ERROR LOGS IDENTIFIED MULTIPLE 571.6240.1 ERROR CODES OCCURRING BETWEEN 19MAY2024 AND 01AUG2024. O SN: (B)(6) THE REVIEW OF THE SUSPECT ETCO2 ERROR LOG DID NOT IDENTIFY ANY ERROR CODES. THE EVENT LOG DID NOT SHOW ANY MALFUNCTION. O SN: (B)(6) THE REVIEW OF THE SUSPECT ETCO2 ERROR LOG DID NOT IDENTIFY ERROR CODES. THE EVENT LOG DID NOT SHOW ANY MALFUNCTION. O SN: (B)(6) THE REVIEW OF THE SUSPECT ETCO2 ERROR LOG DID NOT IDENTIFY ERROR CODES. EVENT LOG. TWO CHANNEL MALFUNCTIONS OCCURRED ON (B)(6) 2024 AT 11:59:31 PM WHICH HAD NOT REGISTERED IN THE ERROR LOG. ¿ THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). NOTE TO REPAIR CENTER THE DEVICE WAS OPENED DURING THE INVESTIGATION, PLEASE ENSURE PROPER ASSEMBLY AND TORQUE SCREWS AS REQUIRED. REPAIR CENTER SHOULD FOLLOW THEIR NORMAL PROCESSING OF THE DEVICE, LOOKING FOR ANY INCIDENTAL ISSUES PRIOR TO RETURNING IT TO THE CUSTOMER. DCHU WILL BE PICKING UP THE COST OF THE DAMAGE ORIDION BOARD BASED ON INVESTIGATION FINDINGS. ROOT CAUSE: THE PROBABLE CAUSE OF THE REPORTED CHANNEL ERROR 571.6241 AND THE UNKNOWN ERROR WHILE RUNNING TASK CO2 ACCURACY TEST/CALIBRATION IS BEING ATTRIBUTED TO A FAULTY ORIDION BOARD AND A LOOSE CONNECTION BETWEEN THE ORIDION BOARD AND THE POWER SUPPLY THROUGH THE J3 CONNECTOR. THE POOR CONNECTION CONDITION IS LIKELY THE RESULT OF AGGRESSIVE HANDLING OR TRANSPORTATION. NOTE THAT IMDRF ANNEX A1603, A0401, C02, C07, D02, D15, G02013 AND G02017 CODES NOT ASSOCIATED WITH THE ROOT CAUSE 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.

    Additional Manufacturer Narrative · 0

    BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. 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 AN INTERMITTENT PROBLEM WITH THE ETCO2 MODULES, WHERE THE "ETCO2 MODULES DO NOT OPERATE USING THE MEDTRONIC FILTER LINES" MICROSTREAM¿ ADVANCE DISPOSABLES PART NO. MVAO AND MVAOH. BD RECEIVED ADDITIONAL INFORMATION. IT WAS REPORTED THAT THE ISSUE OCCURRED WHILE "SETTING UP DISPOSABLE OR WHILE WARMING UP DEVICE." THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER STATED THAT "THE ERRORS THAT HAVE BEEN HAPPENING ON THE FLOOR AND DURING TESTING HAVE BEEN ¿NO BREATHS DETECTED¿, ¿NOT DETECTING DISPOSABLE¿, AND A COUPLE WITH CHANNEL ERRORS AND ERROR CODE 571.6241. DURING PM (PREVENTIVE MAINTENANCE), THE ERROR MESSAGE "UNKNOWN ERROR WHILE RUNNING THE TASK: CO2 SENSOR CALIBRATION FOR (B)(6)[SERIAL NUMBER]" APPEAR ON THE SCREEN. PER CUSTOMER, WHEN THEY FAIL IT'S ALWAYS DURING SENSOR CALIBRATION. THE CUSTOMER STATED THAT SOMETIMES IT WILL PASS PM USING THE CALIBRATED GAS AND THE PM KIT TUBING SETS ONLY TO COME BACK THE SAME DAY WITH THE SAME ISSUES. THE TIMING OF THIS ISSUE COINCIDES WITH SWITCHING THE TUBING SETS FROM MEDTRONIC MICROSTREAM DISPOSABLE TO SALTER LABS AS I HAD NOT SEEN THIS ISSUE BEFORE BUT AFTER TRYING THE ETCO2 WITH MEDTRONIC MICROSTREAM THE ISSUE STILL PERSISTS. WE HAVE RECENTLY FLASHED THESE ETCO2S TO 12.3.0.24 AND MADE SURE ALL HAVE NEW RIGHT IUI¿S WITH THE ¿T¿. BD RECEIVED ADDITIONAL INFORMATION. CUSTOMER STATED THAT THEY WERE "USING THE SALTER LABS TUBING (NOT COMPATIBLE WITH ALARIS ETCO2 DEVICE) WHEN THE PROBLEMS BEGAN. A WEEK OR SO AGO WE WENT TO THE MEDTRONIC TUBING BECAUSE THAT IS WHAT BD APPROVES, BUT THE PROBLEM STILL EXISTS. BOTH TUBING SETS WILL WORK ON SOME MODULES AND NOT ON OTHERS."

    Description of Event or Problem · 0

    IT WAS REPORTED AN INTERMITTENT PROBLEM WITH THE ETCO2 MODULES, WHERE THE "ETCO2 MODULES DO NOT OPERATE USING THE MEDTRONIC FILTER LINES" MICROSTREAM¿ ADVANCE DISPOSABLES PART NO. MVAO AND MVAOH. BD RECEIVED ADDITIONAL INFORMATION. IT WAS REPORTED THAT THE ISSUE OCCURRED WHILE "SETTING UP DISPOSABLE OR WHILE WARMING UP DEVICE." THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER STATED THAT "THE ERRORS THAT HAVE BEEN HAPPENING ON THE FLOOR AND DURING TESTING HAVE BEEN ¿NO BREATHS DETECTED¿, ¿NOT DETECTING DISPOSABLE¿, AND A COUPLE WITH CHANNEL ERRORS AND ERROR CODE 571.6241. DURING PM (PREVENTIVE MAINTENANCE), THE ERROR MESSAGE "UNKNOWN ERROR WHILE RUNNING THE TASK: CO2 SENSOR CALIBRATION FOR M8300S [SERIAL NUMBER]" APPEAR ON THE SCREEN. PER CUSTOMER, WHEN THEY FAIL IT'S ALWAYS DURING SENSOR CALIBRATION. THE CUSTOMER STATED THAT SOMETIMES IT WILL PASS PM USING THE CALIBRATED GAS AND THE PM KIT TUBING SETS ONLY TO COME BACK THE SAME DAY WITH THE SAME ISSUES. THE TIMING OF THIS ISSUE COINCIDES WITH SWITCHING THE TUBING SETS FROM MEDTRONIC MICROSTREAM DISPOSABLE TO SALTER LABS AS I HAD NOT SEEN THIS ISSUE BEFORE BUT AFTER TRYING THE ETCO2 WITH MEDTRONIC MICROSTREAM THE ISSUE STILL PERSISTS. WE HAVE RECENTLY FLASHED THESE ETCO2S TO 12.3.0.24 AND MADE SURE ALL HAVE NEW RIGHT IUI¿S WITH THE ¿T¿. BD RECEIVED ADDITIONAL INFORMATION. CUSTOMER STATED THAT THEY WERE "USING THE SALTER LABS TUBING (NOT COMPATIBLE WITH ALARIS ETCO2 DEVICE) WHEN THE PROBLEMS BEGAN. A WEEK OR SO AGO WE WENT TO THE MEDTRONIC TUBING BECAUSE THAT IS WHAT BD APPROVES, BUT THE PROBLEM STILL EXISTS. BOTH TUBING SETS WILL WORK ON SOME MODULES AND NOT ON OTHERS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242584 ALARIS SYSTEM ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE CCK CAREFUSION SD 8300 10885403830013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown