BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3780057 · Received January 6, 2014

    Report

    Report Number
    1314492-2014-00848
    Event Type
    Malfunction
    Date Received
    January 6, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 31, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP.
    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). THE DEVICE HAS BEEN RETURNED TO BAXTER FOR EVAL. THE INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SPECTRUM PUMP DISPLAYED SYSTEM ERROR 322 ALARMS. THE DEVICE WAS FROM THE NICU DEPARTMENT. THERE WAS NO PT INJURY. NO FURTHER INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8120 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP. 35700

    Patients

    Seq Age Sex Outcome Treatment
    1