BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3853253 · Received January 23, 2014

    Report

    Report Number
    1314492-2014-04182
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 27, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    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). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND TO BE OUT OF SPECIFICATION IN RELATION OT THE REPORTED SYMPTOM, WHICH WAS UNABLE TO BE REPRODUCED. THE DEVICE WAS TESTED FOR 24 HOURS WITH NO OCCURRENCE OF SYSTEM ERROR 322 ALARMS. SYSTEM ERROR 322 ALARMS WERE CONFIRMED THROUGH THE EVENT HISTORY LOG AND WERE DETERMINED TO BE CAUSED BY FAILED UPPER AND LOWER AUXILIARY ASSEMBLIES. THE FAILED UPPER AND LOWER AUXILIARY ASSEMBLIES WERE REPLACED. SYSTEM ERROR 322 WILL OCCUR WHEN THE PUMP TRANSITIONS FROM THE DOOR OPEN STATE TO THE DOOR CLOSE/SET-LOADED STATE AND LOWER LINK SWITCH DOES NOT ACTIVATE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55681 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1