BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PCA MODULE

    MDR report key: 8449958 · Received March 25, 2019

    Report

    Report Number
    2016493-2019-00276
    Event Type
    Injury
    Date Received
    March 25, 2019
    Date of Event
    February 3, 2019
    Report Date
    February 26, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K032233
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT SEQUESTERED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RN INCORRECTLY PROGRAMMED THE CONCENTRATION OF THE DRUG. THE ORDERED DOSE/CONCENTRATION AND ACTUAL SYRINGE WAS 275 MG OF MORPHINE IN 55 ML = 5 MG/ML. THE INITIAL RN PROGRAMMED THE SYRINGE AS 50 MG/50 ML = 1 MG/ML AND THIS ERROR WAS NOT NOTED BY THE 2ND RN DURING THE 2 RN INDEPENDENT CHECK LATER IN THE DAY. BECAUSE OF THIS, FOR 8 HOURS THE PATIENT RECEIVED 5 TIMES THE INTENDED DOSE OF MORPHINE THROUGH THE PCA PUMP. THE PATIENT HAD A LOW SPO2 THE NEXT MORNING, ALONG WITH OTHER SYMPTOMS OF OPIOID OVERDOSE (EMESIS, SOB) HOWEVER THERE WAS NO LASTING HARM AND NO REVERSAL AGENTS GIVEN. THE DOCTOR ORDERED A PCA AND CONTINUOUS INFUSION OF MORPHINE WITH A PCA DOSE OF 2.5 MG, WITH A LOCKOUT INTERVAL OF 15 MINUTES AND 1 HOUR MAX LIMIT OF 19MG AND A CONTINUOUS OF 5MG/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240841 ALARIS PCA MODULE PUMP, INFUSION FRN CAREFUSION 8120

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention