BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3221593 · Received July 3, 2013

    Report

    Report Number
    1314492-2013-00973
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. A SYSTEM ERROR 322 WAS CONFIRMED THROUGH REVIEW OF THE DEVICE'S HISTORY LOG; HOWEVER IT COULD NOT BE REPRODUCED DURING THE EVAL. THE DEVICE WAS RUN FOR (B)(4) HRS WITH NO OCCURRENCE OF SYSTEM ERROR 322. THE CUSTOMER WAS ISSUED A REPLACEMENT DEVICE. 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 SPECTRUM PUMP WAS ALARMING FOR SYSTEM ERROR 322. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303513 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1