BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2782123 · Received October 3, 2012

    Report

    Report Number
    2016493-2012-00431
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    August 28, 2012
    Report Date
    September 18, 2012
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE DEVICES HAVE NOT BEEN RECEIVED FOR EVALUATION. SHOULD THE DEVICE BE RECEIVED FOR EVALUATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FIRE AND SMOKE WAS SEEN COMING FROM BETWEEN TWO PUMP MODULES ON THE LEFT SIDE OF THE PC UNIT WHILE INFUSING ON A PATIENT IN THE OPERATING ROOM. WHEN THE EVENT OCCURRED, THE SYSTEM WAS CONFIGURED WITH TWO PUMP MODULES ON THE RIGHT SIDE AND TWO ON THE LEFT SIDE OF THE PC UNIT. ONE PUMP MODULE WAS PERMANENTLY ATTACHED TO THE RIGHT SIDE OF THE PC UNIT. THE CUSTOMER STATED THAT A SLIMY, CLEAR, STICKY FLUID WAS NOTED ON THE EVENT PUMP MODULES AND THE IUI CONNECTORS. ADDITIONAL EVENT AND PATIENT INFORMATION WAS NOT PROVIDED. IT IS UNKNOWN WHAT MEDICATIONS WERE INFUSING AT THE TIME OF THE EVENT. NO PATIENT HARM OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK THERAPY DATE:| ALARIS PUMP MODULE: SN (B)(4)| ALARIS PUMP MODULE ADMINISTRATION SETS| THERAPY DATE:| THERAPY DATE:| ALARIS PC UNIT, SN (B)(4)| MODEL/LOT NUMBERS UNK| ALARIS PUMP MODULE: SN (B)(4)| THERAPY DATE:| THERAPY DATE:| ALARIS PUMP MODULE: SN (B)(4)