BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8300 ALARIS ETCO2 MODULE

    MDR report key: 11093363 · Received December 30, 2020

    Report

    Report Number
    2016493-2020-84711
    Event Type
    Malfunction
    Date Received
    December 30, 2020
    Report Date
    September 18, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    CCK
    UDI-DI
    10885403830013
    PMA / PMN Number
    K031741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S CONCERNS FOR AN UNKNOWN ERROR WAS CONFIRMED DURING TESTING. TESTING PERFORMED ON THE RETURNED ETCO2 MODULE IN THE ¿AS RECEIVED¿ CONDITION SHOWED THAT WHEN THE DEVICE IS ATTACHED TO A TEST PCU, THE DEVICE IMMEDIATELY ALARMS FOR A ¿SYSTEM ERROR¿ CODE 9-100-1318. TRACKER (B)(4) WAS OPENED TO INVESTIGATE THE ERROR CODE 9-100-1318. THE ERROR IS THE RESULT OF AN INVALID MODEL NUMBER. THE SOURCE ETCO2 MODULE EVENT LOG CONFIRMED THE DEVICE HAD A MODEL AND SERIAL NUMBER OF ¿0¿ (ZERO). THE MODEL NUMBER AND SERIAL NUMBERS WERE CORRECTED USING FLASH TOOLS. FURTHER TESTING CONFIRMED THE ISSUE COULD ALSO BE RESOLVED USING ASM TEST SOFTWARE. ATTEMPTS WERE MADE TO REPLICATE A ¿0¿ MODEL AND SERIAL NUMBER; HOWEVER, TESTING FAILED TO REPLICATE THE ANOMALY BY ENTERING ¿0¿ IN THE MODEL FIELD. IT IS BELIEVED THE DEVICE ENCOUNTERED SOFTWARE CORRUPTION. AS A PRECAUTION THE SERVICE WILL REPLACE THE LOGIC BOARD AND CALIBRATION BEFORE RETURNING THE DEVICE TO THE CUSTOMER. BASED ON THE LOGS, THERE WAS NO PATIENT INVOLVEMENT. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED FROM THE DATE OF THE MANUFACTURE TO DATE OF THE RELEASE OF PRODUCT, WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE, AND PRODUCT WAS RETURNED FOR SERVICING WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD IN THE TRACKWISE WAS PERFORMED FOR THE SN (B)(4) WHICH CONFIRMED NO SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE FOUR ETCO2 DEVICES THAT MALFUNCTIONED. IT IS UNKNOWN WHICH OF THE FOUR DEVICES MALFUNCTIONED DURING PATIENT USE, THEREFORE, THE CUSTOMER IS SENDING IN ALL FOUR DEVICES FOR INVESTIGATIONAL PURPOSES. THE ETCO2 DEVICE ALARMED FOR "ERROR-UNKNOWN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559176 8300 ALARIS ETCO2 MODULE PUMP, INFUSION CCK CAREFUSION SD 8300 10885403830013

    Patients

    Seq Age Sex Outcome Treatment
    1 CAD_ETCO2_DISP,8015,CAD_PCA_TUBE,8120.