BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4802471 · Received May 26, 2015

    Report

    Report Number
    1314492-2015-06293
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 1, 2015
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Removal / Correction Number
    Z-1484-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    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. EVALUATION FOUND THE UPPER LINK SWITCH SLOW TO RESPOND. THE FAILED UPPER AUXILIARY ASSEMBLY WAS REPLACED. 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. THE SOFTWARE WAS UPGRADED PER THE APPROVED REMEDIAL ACTION ACTIVITIES.

    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 INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341073 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1