BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3240919 · Received July 17, 2013

    Report

    Report Number
    1314492-2013-01367
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE EVAL CONFIRMED MULTIPLE SYSTEM ERROR 322 ALARMS THROUGH REVIEW OF THE DEVICE HISTORY LOG. HOWEVER, THE ALARM COULD NOT BE REPRODUCED DURING TESTING. THE DEVICE TESTED FOR 24 HOURS AND FOUND TO PERFORM WITHIN SPEC. THE UPPER AND LOWER AUX WILL BE REPLACED AS THEY ARE BOTH KNOWN CONTRIBUTORS TO SYSTEM ERROR 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP ALARMED FOR A SYSTEM ERROR 322. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332824 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1