BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 1885668 · Received October 25, 2010

    Report

    Report Number
    2016493-2010-00475
    Event Type
    Death
    Date Received
    October 25, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 27, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT INFORMATION REQUESTED. CUSTOMER INDICATED THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. THE CUSTOMER STATED THE PROGRAMMING ERROR WAS DETERMINED TO BE A USER ISSUE; THE NURSE WAS NOT FAMILIAR WITH PROPER PROGRAMMING. THE MANUFACTURING HISTORY RECORD WAS REVIEWED AND NO QUALITY ISSUES WERE FOUND DURING MANUFACTURING BUILD FOR THIS DEVICE SERIAL NUMBER. THE PRODUCT MONITORING AND SERVICE DATABASES WERE REVIEWED AND NO OTHER COMPLAINTS HAVE BEEN OPENED. FOR THIS PUMP, SERIAL NUMBER AND THE SEARCH RESULTS DID NOT UNCOVER ANY RELEVANT ISSUES.

    Description of Event or Problem · 1

    CVICU MANAGER REQUESTED LOG REVIEW TO KNOW IF THE PATIENT RECEIVED TOO MUCH LIDOCAINE OR DIED OF HIS HEART DISEASE. ON (B)(6) 2010 AT 19:10 PM, PT WAS ORDERED LIDOCAINE (CONCENTRATION OF 2GM/500ML) TO INFUSE AT 1MG/MIN. AT 11:00PM LIDOCAINE WAS ORDERED INCREASED TO 2MG/MIN, (30ML/HR). AT 12:00PM ON (B)(6), RAPID RESPONSE TEAM WAS CALLED AND THE NURSE NOTED THE LIDOCAINE WAS INFUSING AT 120ML/HR. CUSTOMER ALSO STATED THERE WAS A DISCREPANCY IN THE NUMBER OF BAGS OF LIDOCAINE SENT FROM PHARMACY. PHARMACY SENT 4 BAGS; ONLY ONE WAS SCANNED INTO THE SYSTEM. CUSTOMER REPORTED PATIENT DIED ON (B)(6) 2010 OF HIS HEART DISEASE. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED AND THIS CONSTITUTES ALL KNOWN INFORMATION REGARDING THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death ALARIS PC UNIT MODEL #8015 SN (B)(4)