BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3222085 · Received July 1, 2013

    Report

    Report Number
    1314492-2013-00943
    Event Type
    Malfunction
    Date Received
    July 1, 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
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. THE SYSTEM ERROR 322 COULD NOT BE REPRODUCED, BUT WAS CONFIRMED DURING THE REVIEW OF THE EVENT HISTORY LOG. SYSTEM ERROR 322 OCCURRED 5 TIMES IN THE EVENT HISTORY LOG. THE DEVICE WAS FOUND TO BE WITHIN SPECIFICATION IN RELATION TO THE REPORTED SYMPTOM, HOWEVER, THE UPPER AND LOWER AUXILIARY ASSEMBLIES WERE REPLACED DUE TO THE EVIDENCE OF SYSTEM ERROR 322 IN THE EVENT HISTORY LOG. 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 THE PUMP ALARMED FOR A SYSTEM ERROR 322 - "LINK SWITCH ERROR (LOW)." IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297485 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP. 35700

    Patients

    Seq Age Sex Outcome Treatment
    1