BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3921456 · Received February 6, 2014

    Report

    Report Number
    1314492-2014-06560
    Event Type
    Malfunction
    Date Received
    February 6, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 10, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED. THE EVALUATION COULD NOT REPRODUCE THE REPORTED SYMPTOM. REVIEW OF THE EVENT HISTORY LOG CONFIRMED THE REPORTED SYMPTOM. THE EVALUATION FOUND THAT THE UPPER AND LOWER AUXILIARY ASSEMBLIES WERE FAILING, WHICH ARE KNOWN CONTRIBUTORS TO THE REPORTED SYMPTOM. THE UPPER AND LOWER AUXILIARY ASSEMBLIES WERE REPLACED. SYSTEM ERROR 322 WILL OCCUR WHEN THE PUMP TRANSITIONS FORM 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 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
    78610 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1