BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3891539 · Received January 31, 2014

    Report

    Report Number
    1314492-2014-05203
    Event Type
    Malfunction
    Date Received
    January 31, 2014
    Date of Event
    December 1, 2013
    Report Date
    January 6, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVAL WAS PERFORMED. THE EVAL PRODUCED A CONSTANT "RELOAD SET" ALARM WHICH CORRESPONDS WITH THE SYMPTOM OF "AIR DETECTOR SENSOR" WHICH WAS REPORTED BY THE CUSTOMER. THIS FALSE MESSAGE WAS CAUSED BY A FAILED UPSTREAM SENSOR. THE UPSTREAM SENSOR WAS REPLACED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68744 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1