BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3221672 · Received July 1, 2013

    Report

    Report Number
    1314492-2013-00958
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY BAXTER. THE EVAL WAS UNABLE TO CONFIRM OR REPRODUCE A FLOW RATE INACCURACY. A FLOW RATE TEST WAS PERFORMED WITH THE DEVICE IN QUESTION, PER THE SPECTRUM PREVENTIVE MAINTENANCE PROCEDURE AND FOUND TO DELIVER WITHIN SPECIFICATION. THE PUMP ALSO PASSED ADDITIONAL FLOW RATE TESTS. FURTHER EVAL FOUND THE UPPER AND LOWER VALVE TRAVEL TO BE BELOW SPECIFICATION. THE VALVES WERE ADJUSTED AND THE DEVICE WAS RE CALIBRATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING, A PUMP DID NOT PASS THE FLOW RATE ACCURACY TEST. THE DEVICE WAS PROGRAMMED TO DELIVER 50ML HOWEVER ONLY 43.428 ML OF FLUID WAS DELIVERED. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297237 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1