BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3921431 · Received February 6, 2014

    Report

    Report Number
    1314492-2014-06547
    Event Type
    Malfunction
    Date Received
    February 6, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 10, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REF NO.: (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVAL WAS PERFORMED. EVAL CONFIRMED THE REPORTED SYMPTOM OF A FAILED AIR DETECTOR THROUGH "AIR-IN-LINE" MESSAGES IN THE HISTORY LOG, BUT COULD NOT REPRODUCE IT. REVIEW OF KNOWN CONTRIBUTORS LED TO THE DETERMINATION THAT THE UPSTREAM SENSOR WAS THE FAILING COMPONENT. THE UPSTREAM SENSOR WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP HAD AN ISSUE WITH THE AIR LINE DETECTOR. IT WAS ALSO REPORTED THAT THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78432 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1