BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS ETCO2 MODULE

    MDR report key: 2781954 · Received October 3, 2012

    Report

    Report Number
    2016493-2012-00424
    Event Type
    Death
    Date Received
    October 3, 2012
    Report Date
    September 4, 2012
    Manufacturer
    CAREFUSION CORP.
    Product Code
    CCK
    PMA / PMN Number
    K031741
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A F/U REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    RECEIVED VAGUE INFO FROM ORIDION/COVIDIEN REP STATING THAT ONE OF THEIR EMPLOYEES REPORTED THAT "A PT AT (B)(6) WAS ON A CAREFUSION PCA PUMP AND BEING MONITORED WITH THE CAREFUSION ETCO2 MODULE. THE PT REPORTEDLY WAS COMPLAINING ABOUT WEARING THE FILTERLINE AND THE NURSE IN TURN DISCONTINUED THE ETCO2 MONITORING AND REMOVED THE FILTERLINE. LATER THE PT REPORTEDLY DIED WHILE ON PCA." THE CUSTOMER DID NOT DIRECTLY REPORT THIS AND THE ORIGINAL SOURCE OF THE INFO IS UNK. ATTEMPTS WERE MADE BY SEVERAL CAREFUSION EMPLOYEES TO OBTAIN FURTHER DETAILS BUT NO FURTHER PT/EVENT INFO IS AVAILABLE. IT IS UNK AT WHICH (B)(6) FACILITY THE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS ETCO2 MODULE CCK CAREFUSION CORP. 8300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death ALARIS PCA: SN UNK| ALARIS PCA ADMINISTRATION SET: MODEL/LOT # UNK| ALARIS PC UNIT: SN UNK