BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3934116 · Received February 1, 2014

    Report

    Report Number
    1314492-2014-07295
    Event Type
    Malfunction
    Date Received
    February 1, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 14, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE REPORTED SYMPTOM OF ERROR 322 WAS NOT REPRODUCED BUT WAS CONFIRMED THROUGH 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. SYSTEM ERROR 322 WILL OCCUR WHEN THE PUMP TRANSITIONS FROM THE DOOR OPEN STATE TO THE DOOR CLOSED/SET-LOADED STATE AND THE LOWER LINK SWITCH DOES NOT ACTIVATE.

    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 INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69372 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1