BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3221932 · Received July 5, 2013

    Report

    Report Number
    1314492-2013-01009
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. EVALUATION COULD NOT REPRODUCE THE REPORTED SYMPTOM. THE DEVICE PASSED FLOW RATE TESTING PER THE SPECTRUM PREVENTIVE MAINTENANCE PROCEDURE, AS WELL AS ADDITIONAL FLOW RATE TESTING. THE DEVICE PASSED UPSTREAM OCCLUSION AND DOWNSTREAM OCCLUSION TESTING PER THE SPECTRUM PREVENTIVE MAINTENANCE PROCEDURE, AS WELL AS ADDITIONAL OCCLUSION TESTING. THE DEVICE WAS FOUND TO BE OPERATING WITHIN SPECIFICATION IN RELATION TO THE REPORTED SYMPTOM. THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INFUSION USING THE SPECTRUM PUMP, "THE PT'S BLOOD CAME THROUGH THE CENTRAL LINE AND INTO THE PIGGY BACK LINE, FILLING THE BAG AND CAUSING IT TO RUPTURE." THE CUSTOMER STATED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308241 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1