BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3792454 · Received December 31, 2013

    Report

    Report Number
    1314492-2013-23935
    Event Type
    Malfunction
    Date Received
    December 31, 2013
    Date of Event
    December 1, 2013
    Report Date
    December 4, 2013
    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). THE DEVICE WAS EVALUATED BY BAXTER. THE EVALUATION WAS ABLE TO REPRODUCE THE REPORTED SYMPTOM OF "DOOR ISSUES - NOT CLOSED." REVIEW OF HISTORY LOG FOUND MULTIPLE "DOOR JAMMED" ALARMS. EVALUATION FOUND FORCE REQUIRED TO SECURE DOOR WHEN A LOADED IV SET IS ABOVE EXPECTED LEVELS DUE TO CRACKED THREADED INSERT BOSS AND RAISED THREADED INSERT CAUSING SEPARATION BETWEEN FRONT CASE AND MECHANICAL ASSEMBLY. THE FRONT CASE HAS BEEN REPLACED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SPECTRUM PUMP HAS "DOOR ISSUES-NOT CLOSED." THER WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683278 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1