BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3891584 · Received January 31, 2014

    Report

    Report Number
    1314492-2014-05220
    Event Type
    Malfunction
    Date Received
    January 31, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 6, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 CONFIRMED (THROUGH THE HISTORY LOG) BUT DID NOT REPRODUCE THE SYSTEM ERROR 105. THE DEVICE WAS OPERATING OUT OF SPEC. PAST REPAIRS HAVE SHOWN THE MOTOR ASSEMBLY TO BE THE FAILING COMPONENT. THE MOTOR ASSEMBLY WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP HAS A SYSTEM ERROR 105. IT WAS ALSO REPORTED THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68970 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1