BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3833586 · Received May 16, 2014

    Report

    Report Number
    2016493-2014-00247
    Event Type
    Death
    Date Received
    May 16, 2014
    Date of Event
    December 26, 2013
    Report Date
    April 30, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 05/16/2014. INTERNAL FILE NUMBER: (B)(4). NO DEVICES RECEIVED, LOG REVIEW ONLY. THE CUSTOMER'S REPORT OF AN OVERINFUSION OF NEO-SYNEPHRINE (PHENYLEPHRINE) WAS CONFIRMED. THE PCU EVENT LOG SHOWS THAT PHENYLEPHRINE NON-WEIGHT BASED DOSING 10MG/250ML ((B)(4)) WAS PROGRAMMED TWO DIFFERENT TIMES ON (B)(6)2013, THE FIRST AT 9:48 AM AND THEN AGAIN AT 10:20 AM. THE CONCENTRATION FOR THIS DRUG WAS 40MCG/ML. INITIALLY THE USER ENTERED 8MCG/MIN FOR THE DOSE, WHICH MADE THE RATE 12ML/HR. BETWEEN 9:39AM AND 7:45 PM, THE DOSE WAS CHANGED MULTIPLE TIMES WHICH RESULTED IN RATES THAT RANGED BETWEEN 12ML/HR AND 270ML/HR. AT 7:48PM, THE USER PROGRAMMED AN INFUSION OF PHENYLEPHRINE NON-WEIGHT BASED DOSING 100MG/250ML ((B)(4)). THE CONCENTRATION FOR THIS DRUG WAS 400MCG/ML. THE USER ENTERED 100MCG/MIN FOR THE DOSE, MAKING THE RATE 27ML/HR. THIS INFUSION RAN AT THESE PARAMETERS FOR APPROX 4 MINUTES BEFORE THE DEVICE WAS CHANNELED OFF. THE ROOT CAUSE OF THE CUSTOMER'S REPORT OF AN OVERINFUSION OF NEO-SYNEPHRINE (PHENYLEPHRINE) WAS IDENTIFIED AS A PROGRAMMING ISSUE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PT WHO WAS RECEIVING NEO-SYNEPHRINE "100/250" (PRESUMED TO MEAN 100MG/250ML) AT AN INTENDED MAXIMUM RATE OF 12ML/H "CODED" AND DID NOT SURVIVE. DURING RESUSCITATION EFFORTS IT WAS NOTED THAT THE INFUSION WAS RUNNING AT 120ML/HR WITH A PROGRAMMED CONCENTRATION OF "10/250" (PRESUMED TO MEAN 10MG/250ML). THE CUSTOMER IS UNSURE WHETHER THE PT'S DEATH IS ATTRIBUTABLE TO THE OVER-INFUSION EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293222 ALARIS PUMP MODULE FRN CAREFUSION CORP 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death ALARIS PUMP MODULE ADMINISTRATION SET,| MODEL/LOT #UNK| ALARIS PC UNIT, SN (B)(4)