BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3921604 · Received February 6, 2014

    Report

    Report Number
    1314492-2014-06570
    Event Type
    Malfunction
    Date Received
    February 6, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 10, 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

    MFR REF NO: (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND EVALUATED. THE DEVICE WAS RECEIVED INOPERABLE DUE TO DOOR NOT FULLY LATCHED MESSAGES. EVAL FOUND THE DOOR ABLE TO LATCH CLOSE WITH A LOADED IV SET, HOWEVER, FORCE REQUIRED TO SECURE DOOR IS ABOVE EXPECTED LEVELS CORRESPONDING WITH THE REPORTED SYMPTOM. DOOR HOOKS AND LATCH PINS WERE REPLACED TO CORRECT THIS CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP DOES NOT RECOGNIZE THAT THE DOOR IS CLOSED. IT WAS ALSO REPORTED THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76513 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1