BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2896708 · Received November 21, 2012

    Report

    Report Number
    1314492-2012-00441
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 23, 2012
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMA EVALUATED THE DEVICE IN QUESTION. WHEN DELIVERING FLUID DURING A PUMP CONTROLLED SECONDARY INFUSION AT A RATE OF 350 ML/HR, NO SIPHONING FROM THE PRIMARY IV CONTAINER WAS OBSERVED. A FLOW RATE TEST WAS PERFORMED WITH THE DEVICE IN QUESTION, PER THE SIGMA PREVENTIVE MAINTENANCE PROCEDURE, AND FOUND TO DELIVER WITHIN SPEC. ADD'L FLOW RATE TESTS WERE PERFORMED WITH THE UNIT PASSING. A REVIEW OF THE HISTORY LOG SHOWS THAT NO SECONDARY INFUSION WAS PROGRAMMED ON THE REPORTED DAY OF THE EVENT. THE LAST SECONDARY INFUSION OBSERVED IN THE DEVICE HISTORY LOG, OCCURRED ON (B)(6) 2012 AND WAS PROGRAMMED AT A RATE OF 999 ML/HR. KNOWN CONDITIONS RESULTING IN FLOW FROM THE PRIMARY CONTAINER DURING A SECONDARY INFUSION SEGMENT INCLUDE AN INADEQUATE HEIGHT DIFFERENTIAL BETWEEN THE PRIMARY AND THE SECONDARY IV CONTAINERS, OR A HIGH FLOW RATE (TYPICALLY ABOVE 300 ML/HR). THE SPECTRUM OPERATORS MANUAL RECOMMENDS THE PRIMARY IV CONTAINER BE PLACED 20 INCHES BELOW THE SECONDARY IV CONTAINER TO PROVIDE A GRAVITY ADVANTAGE THAT ALLOWS FLOW FROM THE SECONDARY IV CONTAINER ONLY, AND WARNS THE USER OF THE POSSIBILITY OF PRIMARY IV CONTAINER SIPHONING WITH FLOW RATES ABOVE 300 ML/HR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SECONDARY INFUSION, MEDICATION WAS DELIVERED FROM THE PRIMARY AND SECONDARY IV CONTAINERS AT THE SAME TIME (MEDICATION, PROGRAMMED AMOUNT AND DELIVERY RATE UNK). THE NURSE RAISED THE SECONDARY CONTAINER AND CLAMPED THE IV LINE FROM THE PRIMARY CONTAINER, HOWEVER CONCURRENT FLOW WAS STILL OBSERVED. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1