BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER HEALTHCARE CORP

    MDR report key: 4843988 · Received June 5, 2015

    Report

    Report Number
    1314492-2015-06554
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 13, 2015
    Manufacturer
    SPECTRUM INFUSION PUMP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Removal / Correction Number
    Z-1484-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. SYSTEM ERROR 322 WILL OCCUR WHEN THE PUMP TRANSITIONS FROM THE DOOR OPEN STATE TO THE DOOR CLOSED/SET-LOADED STATE AND THE LOWER LINK SWITCH DOES NOT ACTIVATE. BAXTER HAS INITIATED A CAPA TO FURTHER INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP DISPLAYED SYSTEM ERROR 322. IT WAS ALSO REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365327 BAXTER HEALTHCARE CORP HEALTHCARE CORP FRN SPECTRUM INFUSION PUMP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1