BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYRINGE PUMP MODULE

    MDR report key: 9177553 · Received October 10, 2019

    Report

    Report Number
    2016493-2019-01269
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Date of Event
    August 31, 2019
    Report Date
    September 11, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K023264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE THE IV SYRINGE PUMP WAS DELIVERING A LOW DOSE EPINEPHRINE INFUSION, THE DEVICE SUDDENLY TURNED OFF AND SHOWED CHANNEL ERROR CODE 13-1033-149. THE EPINEPHRINE INFUSION SET-UP WAS MOVED TO ANOTHER DEVICE MODULE. THERE WAS A BRIEF DROP ON PATIENT'S MEAN ARTERIAL PRESSURE (MAP) BUT IT WAS WITHIN ACCEPTABLE LIMITS AND NO INTERVENTIONS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S EXPERIENCE OF A CHANNEL ERROR 13-1033-149 WAS CONFIRMED IN THE SYRINGE MODULE DEVICE LOGS, HOWEVER THE SEQUENCE THAT TRIGGERED THE ERROR WAS NOT IDENTIFIED. THE SYRINGE MODULE EVENT LOG SHOWS SYRINGE MODULE S/N (B)(4) WAS IN USE SINCE 01:59 PM ON (B)(6) 2019 AND WAS INFUSING AN UNIDENTIFIED MEDICATION AT A RATE OF 1.2ML/HR. THE LAST ENTRY RECORDED IN THE LOG WAS FOR A CHANNEL SELECT AT 7:20 AM. THE NEXT ENTRY RECORDED WAS FOR A POWER ON EVENT AT 8:11 AM ON (B)(6) 2019. THE SYRINGE MODULE ERROR LOG SHOWS A SOFTWARE FAULT (FAULT ID 13-1033-149) OCCURRED AT 10:56 AM ON (B)(6) 2019. THE PCU AND/OR ITS LOGS WERE NOT RECEIVED FOR INVESTIGATION AND THE ACTUAL KEYPRESSES THAT WERE PERFORMED PRIOR TO THE MALFUNCTION WERE NOT ABLE TO BE REPLICATED. THE DEVICE WAS BEING USED FOR TREATMENT. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE OF A CHANNEL ERROR 13-1033-149 WAS NOT IDENTIFIED. PATIENT INFORMATION WAS REQUESTED BUT NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE IV SYRINGE PUMP WAS DELIVERING A LOW DOSE EPINEPHRINE INFUSION, THE DEVICE SUDDENLY TURNED OFF AND SHOWED CHANNEL ERROR CODE 13-1033-149. THE EPINEPHRINE INFUSION SET-UP WAS MOVED TO ANOTHER DEVICE MODULE. THERE WAS A BRIEF DROP ON PATIENT'S MEAN ARTERIAL PRESSURE (MAP) BUT IT WAS WITHIN ACCEPTABLE LIMITS AND NO INTERVENTIONS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970052 ALARIS SYRINGE PUMP MODULE INFUSION PUMP FRN CAREFUSION 8110

    Patients

    Seq Age Sex Outcome Treatment
    1 SYR TUBING,8015| TD (B)(6) 2019