BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2990221 · Received February 6, 2013

    Report

    Report Number
    1314492-2013-00072
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Report Date
    January 8, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF THE HISTORY LOG SHOWS THAT DURING THE LAST INFUSION SEGMENT, A SECONDARY INFUSION WAS PROGRAMMED AT A RATE OF 999 ML/HR FOR A VTBI OF 250ML. KNOWN CONDITIONS RESULTING IN FLOW FROM THE PRIMARY CONTAINER DURING A SECONDARY INFUSION SEGMENT INCLUDE A HIGH FLOW RATE (TYPICALLY ABOVE 300ML/HR). THE SPECTRUM OPERATOR¿S MANUAL WARNS THE USER OF THE POSSIBILITY OF PRIMARY IV CONTAINER SIPHONING WITH FLOW RATES ABOVE 300ML/HR. THE SPECTRUM OPERATOR¿S MANUAL ALSO RECOMMENDS THAT WITH SECONDARY RATES ABOVE 300ML/HR, TO LOOK FOR AND CLAMP OFF PRIMARY LINE SIPHONING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PUMP CONTROLLED SECONDARY INFUSION, THE PRIMARY AND SECONDARY MEDICATIONS WERE DELIVERED SIMULTANEOUSLY (MEDICATIONS, PROGRAMMED AMOUNTS AND DELIVERY RATES UNK). IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49800 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1