BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2926532 · Received January 16, 2013

    Report

    Report Number
    2016493-2013-00062
    Event Type
    Death
    Date Received
    January 16, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 19, 2012
    Manufacturer
    CAREFUSION CORPORATION
    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). AN EVENT LOG REVIEW IS PENDING; THE LOGS HAVE BEEN RECEIVED; HOWEVER, ALTHOUGH REQUESTED, THE CUSTOMER HAS NOT YET PROVIDED THEIR DATASET. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. NO DEVICES RECEIVED, LOG REVIEW PENDING.

    Description of Event or Problem · 1

    THE CUSTOMER REQUESTED AN EVENT LOG REVIEW TO IDENTIFY PROGRAMMING FOR A LIDOCAINE INFUSION BECAUSE A PT DEATH OCCURRED. MULTIPLE MEDICATIONS WERE PROGRAMMED; HOWEVER, ALTHOUGH REQUESTED, PROGRAMMING DETAILS HAVE NOT BEEN PROVIDED FOR ANY INFUSION. THE CUSTOMER DOES NOT ALLEGE A DEVICE MALFUNCTION BUT DOES BELIEVE THAT THERE MAY HAVE BEEN A USER PROGRAMMING ISSUE. CUSTOMER STATED THAT NO ADDITIONAL EVENT OR PT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23486 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death ALARIS PC UNIT, MODEL 8015, SN UNK| ALARIS PUMP MODULE ADMIN SET, MODLE/LOT # UNK