BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3221495 · Received July 3, 2013

    Report

    Report Number
    1314492-2013-00979
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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, AS WELL AS REPRODUCED DURING EVAL. THIS ERROR WAS CAUSED BY A FAILED LOWER LINK SWITCH. THE LINK SWITCH WAS FOUND TO HAVE CONTAMINATION ON THE SWITCH SPRING, THE METAL CONTACT AT THE BOTTOM OF THE SWITCH, AND ON THE BACKSIDE BETWEEN THE SWITCH AND THE FLEX. THE LOWER AUX WAS REPLACED. 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 CONSTANTLY FOR SYSTEM ERROR 322. IT WAS ALSO REPORTED THAT THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303494 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1