BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3223905 · Received July 2, 2013

    Report

    Report Number
    1314492-2013-00961
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY BAXTER. BAXTER'S ENGINEERING EVAL CONFIRMED THE REPORTED SYMPTOM THROUGH HISTORY LOG REVIEW. THE INVESTIGATION WAS UNABLE TO REPRODUCE THE REPORTED SYMPTOM OF EC 322 AFTER THE UNIT WAS RUN FOR 60+ HOURS. THE BAXTER DEVICE EVAL IS STILL IN PROGRESS. WHEN THE EVAL IS COMPLETED A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 PUMP IS CONSTANTLY ALARMING FOR SYSTEM ERROR 322. IT WAS ALSO REPORTED THAT THERE WAS NO ASSOCIATED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301768 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1