BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 5953405 · Received September 15, 2016

    Report

    Report Number
    2016493-2016-00711
    Event Type
    Injury
    Date Received
    September 15, 2016
    Date of Event
    August 24, 2016
    Report Date
    August 25, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT LOGS HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF A CHANNEL ERROR 13-1033-149 WAS CONFIRMED. ANALYSIS OF THE PCU EVENT LOG SHOWS THAT AT 5:51PM ON (B)(6) 2016 THE PUMP MODULE WAS PROGRAMMED TO INFUSE AT A RATE OF 19ML/HR WITH A VTBI OF 500ML. AT 5:57PM, THE RATE WAS CHANGED TO 9.375ML/HR. AT 5:59PM, THE RATE WAS CHANGED TO 3.75ML/HR. AT 6:06PM, THE RATE WAS CHANGED BACK TO 9.375ML/HR. AT 6:07PM, NETWORK COMMUNICATION WAS LOST. THE NEXT ENTRY RECORDED IN THE EVENT LOG IS A POWER ON EVENT AT 7:39 AM ON (B)(6) 2016. THE ROOT CAUSE OF THE CHANNEL ERROR WAS NOT IDENTIFIED. NO DEVICE WAS RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE HAD A CHANNEL ERROR DURING A LEVOPHED INFUSION. THE PATIENT'S DIASTOLIC BLOOD PRESSURE DROPPED INTO THE 70'S DURING THE TIME IT TOOK TO CHANGE OUT THE SYSTEM. NO FURTHER INFORMATION IS AVAILABLE; THERE IS NO REPORT OF MEDICAL INTERVENTION OR LASTING HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605316 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PRI TUBING,8015