BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3221943 · Received July 5, 2013

    Report

    Report Number
    1314492-2013-01015
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Date of Event
    June 1, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. EVALUATION FOUND THE UPSTREAM SENSOR TO BE FAILING, AS EVIDENCED BY THE SIGNAL OUTPUT OF THE UPPER SENSOR BEING OUT OF SPECIFICATION, MAKING THE DEVICE MORE SENSITIVE FOR AIR ALARMS. THE DEVICE WAS NOT IN SPECIFICATION IN RELATION TO THE REPORTED SYMPTOM. THE UPSTREAM SENSOR ASSEMBLY WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP HAS AN "AIR IN LINE FAILURE." THE CUSTOMER STATED THAT THERE WAS NO AIR IN THE LINE AND THAT THE ISSUE WAS DISCOVERED DURING PM TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307125 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1