BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3884016 · Received June 11, 2014

    Report

    Report Number
    2016493-2014-00281
    Event Type
    Death
    Date Received
    June 11, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 20, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED OVER-INFUSION DUE TO PROGRAMMING WAS CONFIRMED AS REPORTED. THE CUSTOMER DID NOT RETURN ANY DEVICE FOR INVESTIGATION, ONLY REQUESTED A LOG REVIEW ABOUT PROGRAMMING. THE USER HAD SELECTED THE DRUG BIVALIRUDIN FROM THE DRUG LIBRARY INSTEAD OF THE REPORTED INTENDED DRUG OF ESMOLOL WHICH HAS A TRADE NAME AS BREVIBLOC. IT WAS REPORTED THAT THE USER DURING PROGRAMMING HAD RECEIVED A GREEN ALERT SCREEN ASKING FOR A SECOND NURSE VERIFICATION BUT THIS COULD NOT BE CONFIRMED. KEY PRESS REPLICATION WAS PERFORMED USING THE RECEIVED DATA SET LOADED INTO A PCU. IN THAT REPLICATION SCENARIO, AN ALERT WAS DISPLAYED STATING "HIGH RISK! CATH LAB USE ONLY" WITH THE USER NEEDLING TO SELECT THE CONFIRM KEY. THE RECEIVED DATA SET WAS A DRAFT VERSION IN WHICH THE CUSTOMER'S PHARMACIST REPORTED MAKING NO CHANGES TO THE DRUG LIBRARY, ONLY BAR CODING. THE ORIGINAL VERSION IN USE AT THE TIME OF THE EVENT WAS NO LONGER AVAILABLE. THE USER RAN THE INFUSION AT THE RATE OF 354 ML/H BASED ON THE PARAMETERS ENTERED, BYPASSING THE RECEIVED GUARDRAILS ALERT THAT THE DOSE ENTERED EXCEEDED THE LIMIT OF 1.75MG/KG/H. THE USER RAN THE INFUSION FOR APPROXIMATELY 23 MINUTES BEFORE TERMINATING IT. IT WAS NOTED IN THE LOG THAT THE USER HAD TO RESTART THE INFUSION A COUPLE OF TIMES DURING THE NOTED TIME PERIOD AND HAD BYPASSED THE RETURNING GUARDRAILS ALERT REGARDING THE DOSING. NO DEVICE MALFUNCTION WAS ALLEGED BY THE CUSTOMER AND NONE IS BELIEVED TO HAVE OCCURRED DURING THE REPORTED OVER-INFUSION INCIDENT. THE ROOT CAUSE FOR THE CUSTOMER'S REPORTED EXPERIENCE IS BEING ATTRIBUTED TO PROGRAMMING AND NOT THE RESULT OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN OVER INFUSION DUE TO A PROGRAMMING ERROR THAT MAY HAVE CAUSED THE DEATH OF A PATIENT. THE MEDICATION INVOLVED IS BREVIBLOC PREMIXED INJECTION (ESMOLOL HYDROCHLORIDE) 2,500 MG/250 ML. SCANNING THE MEDICATION BAG INTO THE PUMP WAS NOT AN OPTION SO THE USER MANUALLY PROGRAMMED THE INFUSION. IT IS BELIEVED THE MEDICATION SELECTED WAS BIVALIRUDIN. A SOFT ALERT WAS DISPLAYED "EXCEEDING THE MAX RATE OF 1.75MG/HR; THIS WARNING WAS BYPASSED." THE RATE WAS DISPLAYED AS 354ML/HR AND WITHIN 20 MINUTES THE PATIENT ARRESTED REQUIRING INTUBATION. THE PATIENT EXPIRED LATER THAT DAY AT 1934.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344342 ALARIS PUMP MODULE FRN CAREFUSION CORP 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death ALARIS PUMP MODULE TUBING: MODEL/LOT UNK| ALARIS PUMP MODULE, SN (B)(4)| ALARIS PC UNIT, SN (B)(4)| ALARIS PUMP MODULE, SN (B)(4)| ALARIS PUMP MODULE, SN (B)(4)