BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2831010 · Received November 2, 2012

    Report

    Report Number
    1314492-2012-00395
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 5, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FLOW RATE TEST WAS PERFORMED WITH THE DEVICE IN QUESTION, PER THE SIGMA PREVENTIVE MAINTENANCE PROCEDURE AND FOUND TO DELIVER WITHIN SPECIFICATION. AN ADDITIONAL FLOW RATE TEST WAS PERFORMED WITH THE UNIT PASSING. A REVIEW OF THE HISTORY LOG SHOWS THAT DURING THE REPORTED EVENT, THE USER ENTERED A RATE OF 95ML/HR AND A VTBI OF 100ML. THE USER EXCEEDED THE SOFT LIMITS (8-16ML/HR) SET IN THE MASTER DRUG LIBRARY (MDL), AND THE VALUE WAS ACCEPTED BY THE USER. THE HISTORY LOG ALSO SHOWS THAT THE PUMP RAN FOR APPROXIMATELY 55 MINUTES THEN ALARMED TWICE FOR AIR-IN-LINE. THE AVAILABLE INFORMATION SUGGESTS THAT THE USER ENTERED INCORRECT INFUSION PARAMETERS AND ACCEPTED A RATE THAT EXCEEDED THE SOFT LIMITS SET IN THE CUSTOMER'S MDL. NO MALFUNCTION COULD BE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP WAS INVOLVED IN AN OVER INFUSION OF FENTANYL R.O.B.I. EPIDURAL. IT WAS REPORTED THAT THE PUMP WAS PROGRAMMED TO INFUSE AT A RATE OF 14ML/HR WITH A VTBI OF 95ML, HOWEVER, IT WAS OBSERVED THAT THE PUMP DELIVERED 87.7ML IN 8 MINUTES. THE CUSTOMER STATED THAT THE PUMP DISPLAYED A RATE OF 95ML/HR WITH A VTBI OF 12.3ML. IT WAS REPORTED THE PUMP DID NOT STOP AT 12.3ML, NOR DID IT ALARM. IT WAS REPORTED THAT THE IV SET USED AT THE TIME OF THE EVENT WAS BAXTER 1C8109S AND THAT THE EPIDURAL BAG WAS HANGING APPROXIMATELY 12-18 INCHES ABOVE THE PUMP. THE CUSTOMER STATED THAT AS A RESULT, THE EPIDURAL INFUSION WAS DISCONTINUED AND THE PATIENT REQUIRED CONTINUOUS "AT BEDSIDE ONE ON ONE NURSING CARE." IT WAS ALSO REPORTED THAT THE VITAL SIGNS WERE CHECKED EVERY 5 MINUTES AND THE PATIENT RECEIVED AN IV BOLUS OF 250ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1 Other