BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3222061 · Received July 1, 2013

    Report

    Report Number
    1314492-2013-00946
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. EVALUATION CONFIRMED THE REPORTED SYMPTOM THROUGH THE DEVICE HISTORY LOG BUT WAS UNABLE TO REPRODUCE. THE DEVICE MEETS SPECIFICATION FOR THE REPORTED SYMPTOM OF EC 322. 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. THE UPPER AND LOWER AUX WILL BE REPLACED AS THEY ARE KNOWN CONTRIBUTORS TO THE REPORTED SYMPTOM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE ALARMED FOR SYSTEM ERROR 322. IT WAS ALSO REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297625 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1