BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3220662 · Received June 25, 2013

    Report

    Report Number
    1314492-2013-00851
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    March 1, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED. THE EVALUATION COULD NOT REPRODUCE A FALSE UPSTREAM OCCLUSION ALARM. THE DEVICE WAS TESTED FOR 24 HOURS WITH NO OCCURRENCE OF AN UPSTREAM OCCLUSION ALARM. AN UPSTREAM OCCLUSION TEST WAS PERFORMED PER THE SPECTRUM PREVENTIVE MAINTENANCE PROCEDURE AND THE DEVICE WAS FOUND TO DELIVER WITHIN SPECIFICATION. THE PUMP ALSO PASSED ADDITIONAL UPSTREAM OCCLUSION TESTS. REVIEW OF THE DEVICE HISTORY LOG SHOWS THAT THE PUMP ALARMED FOR AN UPSTREAM OCCLUSION MULTIPLE TIMES, HOWEVER NO MALFUNCTION COULD BE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING, A PUMP ALARMED FOR AN UPSTREAM OCCLUSION WAS PRESENT. THE DEVICE WAS PROGRAMMED TO DELIVER AT A RATE OF 999 ML/HR AT 62 DEGREES FAHRENHEIT. THE PUMP ALARMED FOR 3 UPSTREAM OCCLUSION ALARMS WITHIN 2.5 HOURS AND THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288586 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1