BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3221598 · Received July 3, 2013

    Report

    Report Number
    1314492-2013-00977
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY BAXTER. THE ENGINEERING EVAL OF THIS UNIT FOUND THE UPSTREAM SENSOR VALUES TO BE LOW. ADDITIONALLY, EVAL OF THE SENSOR FOUND FINE CRACKS IN THE UPSTREAM SENSOR TAIL WHICH ARE KNOWN TO CAUSE INTERMITTENT UPSTREAM OCCLUSION ALARMS. THE UPSTREAM SENSOR WILL BE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP INTERMITTENTLY ALARMS FOR UPSTREAM OCCLUSION WHEN NO OCCLUSION IS PRESENT. THE CUSTOMER STATED THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303690 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP. 35700

    Patients

    Seq Age Sex Outcome Treatment
    1