BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS ETCO2 MODULE

    MDR report key: 4960402 · Received August 3, 2015

    Report

    Report Number
    2016493-2015-00551
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    January 14, 2015
    Report Date
    January 14, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CCK
    PMA / PMN Number
    K031741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT THAT THE SYSTEM ALARMED FOR CHANNEL ERROR DURING PATIENT TRANSPORT WAS CONFIRMED BY REVIEW OF THE EVENT AND ERROR LOGS. BASED ON THE LOG REVIEW AND DEVICE INSPECTION RESULTS, THE CHANNEL DISCONNECT IS BELIEVED TO HAVE OCCURRED BETWEEN THE RIGHT IUI CONNECTOR ON THE PC UNIT AND THE LEFT IUI CONNECTOR ON THE PCA MODULE. THE IUI CONNECTORS WERE INSPECTED. A HEAVY CONTAMINANT FILM WAS PRESENT ON THE RIGHT IUI CONNECTOR OF THE PCU. THIS CAUSED AN INTERMITTENT ELECTRICAL CONNECTION WHICH RESULTED IN THE CHANNEL DISCONNECT ALARMS AND THE CHANNEL MALFUNCTION ERROR CODE 511-2010 THAT OCCURRED ON THE ETCO2 MODULE. TESTING WAS PERFORMED WITH THE SYSTEM PROGRAMMED AND INFUSIONS WERE STARTED WITH THE PARAMETERS FOUND IN THE EVENT LOG REVIEW. THE SYSTEM WAS AGGRESSIVELY MANIPULATED IN AN ATTEMPT TO RECREATE THE CHANNEL DISCONNECT EVENT. NO CHANNEL DISCONNECT ALARMS OCCURRED DURING THIS TEST. THE ROOT CAUSE OF THE REPORTED CHANNEL DISCONNECT WAS FLUID CONTAMINATION ON THE IUI CONNECTOR CONTACTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PCA INFUSION WAS INITIATED IN THE PACU. THE PCA EQUIPMENT ALARMED FOR CHANNEL ERROR DURING PATIENT TRANSPORT. THE DEVICES WERE REPLACED AND INFUSION RESTARTED WITHOUT INTERRUPTION IN PATIENT CARE. THERE WAS NO REPORT OF ANY PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504944 ALARIS ETCO2 MODULE ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE23 CCK CAREFUSION 8300

    Patients

    Seq Age Sex Outcome Treatment
    1