BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3921443 · Received February 6, 2014

    Report

    Report Number
    1314492-2014-06562
    Event Type
    Malfunction
    Date Received
    February 6, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 10, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    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). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED. THE EVALUATION CONFIRMED AND REPRODUCED THE REPORTED SYMPTOM. THE EVALUATION FOUND THAT THE FORCE REQUIRED TO SECURE THE DOOR WITH A LOADED IV SET WAS ABOVE EXPECTED LEVELS DUE TO A CRACKED THREADED INSERT BOSS AND A RAISED THREADED INSERT, RESULTING IN SEPARATION BETWEEN THE FRONT CASE AND MECHANICAL ASSEMBLY. THE FRONT CASE ASSEMBLY WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP ALARMED DOOR NOT FULLY LATCHED. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78541 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1