BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4456701 · Received January 16, 2015

    Report

    Report Number
    1314492-2015-00849
    Event Type
    Malfunction
    Date Received
    January 16, 2015
    Date of Event
    December 1, 2014
    Report Date
    December 24, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Removal / Correction Number
    Z-1484-2014
    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 DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE REPORTED SYSTEM ERROR 322 WHICH WAS NOT REPRODUCED. SYSTEM ERROR 322 WAS CONFIRMED THROUGH REVIEW OF THE EVENT HISTORY LOG. THE SOFTWARE WAS UPGRADED TO CORRECT THIS ISSUE PER THE APPROVED REMEDIAL ACTION ACTIVITIES. SPECTRUM INFUSION PUMP INFUSION PUMP BAXTER HEALTHCARE CORP

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP DISPLAYED SYSTEM ERROR 322. ANY PT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40490 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1