BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3935126 · Received February 3, 2014

    Report

    Report Number
    1314492-2014-05621
    Event Type
    Malfunction
    Date Received
    February 3, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 7, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF NO.: (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED. THE EVALUATION CONFIRMED AND REPRODUCED THE UNDETECTED UPSTREAM OCCLUSION CAUSED BY A DRIED SOLUTION ON THE UPSTREAM SENSOR ASSEMBLY. THE DRIED SOLUTION WAS REMOVED AND THE DEVICE WAS CALIBRATED TO ENSURE PROPER OCCLUSION DETECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP WOULD NOT DETECT AN UPSTREAM OCCLUSION. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69457 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1