BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8300 ALARIS ETCO2 MODULE

    MDR report key: 11144509 · Received January 10, 2021

    Report

    Report Number
    2016493-2021-06047
    Event Type
    Malfunction
    Date Received
    January 10, 2021
    Report Date
    January 23, 2020
    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
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. BASED ON THE FILE REVIEW, COMPLAINT ESCALATIONS, INFUSION PRODUCTS GLOBAL CUSTOMER SUPPORT OPERATIONS. 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 NOT RETURNED FOR SERVICING WHICH NOT 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.

    Description of Event or Problem · 1

    BD QUALITY ADVOCATE, THIS NOTIFICATION IS TO INFORM YOU THAT A NEW CASE HAS BEEN CREATED WITH THE COMPLAINT TYPE CATEGORY INFUSION CA. (B)(4). CASE DESCRIPTION: CALLER HAS AN 8300 MODULE GIVING A 571.6241 ERROR. SN: (B)(4). FAILURE DEVICE TYPE: FAILURE PROBLEM TYPE: FAILURE MODE: CASE RESOLUTION: USED KA 12133 ALARIS INFUSION ERROR 571.6240 / 571.6241 IN TROUBLESHOOTING. RECOMMENDED TO SEND IN UNIT FOR FLAT RATE LEVEL REPAIR FOR REPLACEMENT OF ETCO2 MODULE. BIOMED ENDED CALL. REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40816 8300 ALARIS ETCO2 MODULE PUMP,INFUSION CCK CAREFUSION SD 8300 10885403830013

    Patients

    Seq Age Sex Outcome Treatment
    1