BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3223893 · Received July 2, 2013

    Report

    Report Number
    1314492-2013-00960
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY BAXTER. THE UNIT PASSED FLOW RATE TESTING PER THE SPECTRUM SERVICE MANUAL. THE PUMP PASSED ADD'L FLOW RATE TESTS AS WELL. HOWEVER, WHEN TESTED FOR FLOW RATE ACCURACY USING THE PARAMETERS FOUND IN THE HISTORY LOG (300 ML/HR WITH A VOLUME TO BE INFUSED OF 20 ML), THE UNIT WAS FOUND TO BE SLIGHTLY UNDER-INFUSING, DELIVERING 18.641 ML. THE PUMP WAS NOT WITHIN SPEC IN RELATION TO THE REPORTED SYMPTOM. THE UNIT WAS NOT UNDER-INFUSING AT THE MAGNITUDE DESCRIBED BY THE CUSTOMER. THE PUMP WAS RE-CALIBRATED TO CORRECT THIS FLOW RATE DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP WAS EXPERIENCING A DEFICIENCY IN FLOW RATE ACCURACY. IT WAS REPORTED THAT "IF 20 ML WAS PROGRAMMED, ONLY 10 ML WAS DELIVERED." IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300966 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1