BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2950499 · Received January 23, 2013

    Report

    Report Number
    2016493-2013-00069
    Event Type
    Injury
    Date Received
    January 23, 2013
    Report Date
    January 11, 2013
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE DEVICE HAS NOT BEEN RETURNED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    BIOMED REPORTED THAT AN ALARIS INFUSION DEVICE STARTED SMOKING WHILE IN USE ON A PATIENT. THE NURSE REPORTED SHE SAW SMOKE COMING OUT OF DEVICE. SHE REMOVED IT FROM THE PATIENT IMMEDIATELY. NO PATIENT OR USER HARM REPORTED AND NO MEDICAL INTERVENTION REQUIRED. CUSTOMER STATED NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33654 ALARIS PUMP MODULE FRN CAREFUSION CORP 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other MODEL/LOT UNK| ALARIS PUMP MODULE ADMINISTRATION SET| ALARIS PC UNIT, SN UNK