BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3913007 · Received January 14, 2014

    Report

    Report Number
    1314492-2014-03127
    Event Type
    Malfunction
    Date Received
    January 14, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 18, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF NO.: (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE REPORTED "SYSTEM ERROR 322" WAS CONFIRMED THROUGH THE REVIEW OF THE EVENT HISTORY LOG. IT HAS BEEN DETERMINED THAT THE UPPER AND LOWER AUXILIARY WERE THE FAILING COMPONENTS WHICH CAUSED THIS ERROR. THE UPPER AND LOWER AUXILIARY WERE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP HAD A SYSTEM ERROR 322. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36659 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1