BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8300 ALARIS ETCO2 MODULE

    MDR report key: 10640014 · Received October 7, 2020

    Report

    Report Number
    2016493-2020-18122
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Report Date
    February 14, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    CCK
    PMA / PMN Number
    K031741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE SERVICE REPAIR PROCESS. FAILURE DATA AND PARTS-USED INFORMATION WERE REVIEWED FOR THE SAP AND TRACK WISE FILES AND FOUND RELEVANT TO THE SERVICE REPAIR. A REVIEW OF THE SOURCE DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE CORRESPONDING TO THIS SERVICE NOTIFICATION NUMBER. THE DEVICE WAS PREVIOUSLY RETURNED FOR ISSUES UNRELATED TO THE REPORTED COMPLAINT OR SERVICE HISTORY. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED 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. CAPA REFERENCE: (B)(4). THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    (B)(4). FRONT CASE CRACKED L AND R NEAR THE MICROSTREAM. ERROR 511 .2010 CAUSE BY U7 SOCKET. USE CO # 513743 TO FIX PROBLEM (U7 SOCKET). WE DO NOT HAVE TOOL TO REMOVE SOCKET . (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108953 8300 ALARIS ETCO2 MODULE PUMP, INFUSION CCK CAREFUSION SD 8300

    Patients

    Seq Age Sex Outcome Treatment
    1