BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3792477 · Received December 31, 2013

    Report

    Report Number
    1314492-2013-23940
    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
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED. EVALUATION COULD NOT REPRODUCE THE REPORTED SYMPTOM SYSTEM ERROR 322. REVIEW OF THE HISTORY LOG CONFIRMED THE REPORTED SYMPTOM. REVIEW OF KNOWN CONTRIBUTORS LED TO THE DETERMINATION THAT THE UPPER AND LOWER AUXILIARY ASSEMBLIES WERE THE FAILING COMPONENTS. THE UPPER AND LOWER AUXILIARY ASSEMBLIES WERE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP ALARMED SYSTEM ERROR 322. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683171 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1