BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS ETCO2

    MDR report key: 11728328 · Received April 26, 2021

    Report

    Report Number
    2016493-2021-503722
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Report Date
    April 16, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    CCK
    PMA / PMN Number
    K031741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION IN E2. TECHNICAL SUPPORT PERFORMED TROUBLESHOOTING OVER TO DETERMINE THE CUSTOMER REPORTED ISSUE OF NPI ETCO2 UNIT FAILING LEAK DOWN TEST. TECHNICAL SUPPORT: 1. TECH HAS (2) ETCO2 UNITS BOTH FAILING LEAK DOWN TEST DURING PM TEST. 2. TECH WILL SEND THE UNITS IN FOR SERVICES REPAIR. 3. CONFIRM LEVEL ONE QUOTE FOR REPAIR. 1. TECH HAS (2) ETCO2 UNITS BOTH FAILING LEAK DOWN TEST DURING PM TEST. 2. TECH WILL SEND THE UNITS IN FOR SERVICES REPAIR. 3. CONFIRM LEVEL ONE QUOTE FOR REPAIR. SYMPTOMS/SYSTEM EFFECT: HOW TO TEST LEAK-DOWN TEST JIG. SOURCE: BD ALARIS¿ SYSTEM MAINTENANCE MODEL 8975, V12.1.0. SOFTWARE USER MANUAL. STEPS TO SOLVE (INTERNAL). SOLUTION/WORKAROUND SUMMARY: HOW TO TEST LEAK-DOWN TEST JIG. SUGGESTED MESSAGING: HAVE YOU VERIFIED YOUR LEAK-DOWN TEST JIG IS NOT LEAKING? HIGH LEVEL STEPS/PROCEDURE: SET UP THE LEAK-DOWN TEST. ENSURE THE PRESSURE SENSOR IS SET TO MMHG. SLOWLY PULL THE SYRINGE PLUNGER UNTIL THE PRESSURE SENSOR READS A VACUUM OF BETWEEN -256 MMHG AND -270 MMHG. STOP PULLING THE PLUNGER AND NOTE THE VACUUM READING AS ¿V1.¿. STOP PULLING THE PLUNGER AND NOTE THE VACUUM READING AS ¿V1.¿. IF YOU CANNOT ACHIEVE THE VACUUM RANGE INDICATED IN STEP 3, DO THE FOLLOWING: TIGHTEN THE CONNECTIONS BETWEEN ALL PARTS IN THE LEAK-DOWN TEST JIG AND REPEAT THE TEST. IF THE TEST STILL FAILS, REPLACE PART #3 (ANTI-SIPHON VALVE) AND PART #4 (3-WAY LUER STOPCOCK), TIGHTEN THE CONNECTIONS BETWEEN ALL OF THE PARTS, AND REPEAT THE TEST. IF THE TEST FAILS AGAIN, BUILD A NEW LEAK-DOWN TEST JIG WITH ALL NEW PARTS, TIGHTEN THE CONNECTIONS BETWEEN ALL OF THE PARTS, AND REPEAT THE TEST. IF THE TEST FAILS AGAIN, CONTACT CAREFUSION TECHNICAL SUPPORT (1-888-812-3229). AFTER 20 SECONDS HAVE ELAPSED, NOTE THE VACUUM READING ON THE PRESSURE SENSOR AS ¿V2¿ AND DETERMINE ONE OF THE FOLLOWING: IF V2-V1 = 15 MMHG, THE LEAK-DOWN TEST JIG HAS PASSED THE TEST AND MAY BE USED FOR AN ETCO2 MODULE LEAK-DOWN TEST. IF V2-V1 > 15 MMHG, THE LEAK-DOWN TEST JIG HAS A LEAK. PERFORM THE ITEMS IN STEP 4 TO STOP THE LEAK. THE CUSTOMER REPORTED PROBLEM WAS NOT CONFIRMED. A SERIAL NUMBER WAS NOT PROVIDED THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED. H3 OTHER TEXT : TECH SUPPORT PERFORMED TROUBLESHOOTING OVER THE PHONE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE FAILED PREVENTIVE MAINTENANCE FOR LEAK DOWN TEST. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    NO DEVICE WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FAILED PREVENTIVE MAINTENANCE FOR LEAK DOWN TEST. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621799 ALARIS ETCO2 PUMP, INFUSION CCK CAREFUSION SD 8300

    Patients

    Seq Age Sex Outcome Treatment
    1