BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3191160 · Received June 14, 2013

    Report

    Report Number
    1314492-2013-00783
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS REC'D AND EVALUATED BY BAXTER. DURING THE BAXTER EVALUATION IT WAS FOUND THAT THE DEVICE FAILED UPSTREAM OCCLUSION TESTING DUE TO A FAILED UPSTREAM SENSOR. THE UPSTREAM SENSOR WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A BAXTER DEVICE EVALUATION THAT A PUMP FAILED UPSTREAM OCCLUSION TESTING. THERE WAS NO ASSOCIATED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272342 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1