BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3891022 · Received January 31, 2014

    Report

    Report Number
    1314492-2014-05312
    Event Type
    Malfunction
    Date Received
    January 31, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 6, 2014
    Manufacturer
    SIGMA INTL.
    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. EVALUATION CONFIRMED THE REPORTED SYMPTOM OF SYSTEM ERROR 322 THROUGH THE HISTORY LOG, BUT COULD NOT REPRODUCE IT. 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 CODE 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 PUMP ALARMED SYSTEM ERROR 322. IT WAS ALSO REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67461 SPECTRUM INFUSION PUMP INFUSION PUMP FRN SIGMA INTL. 35700

    Patients

    Seq Age Sex Outcome Treatment
    1