BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3222010 · Received July 5, 2013

    Report

    Report Number
    1314492-2013-01036
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    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 RETURNED AND EVALUATED BY BAXTER. EVALUATION REPRODUCED THE REPORTED SYMPTOM. THE SPECIFIC COMPONENT RESPONSIBLE FOR THE FAILURE COULD NOT BE IDENTIFIED. THE DEVICE WAS NOT WITHIN SPECIFICATION IN RELATION TO THE REPORTED SYMPTOM. THE UPPER AUXILIARY ASSEMBLY AND THE LOWER AUXILIARY ASSEMBLY ARE KNOWN CONTRIBUTORS TO THIS ALARM AND HAVE BEEN 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 PUMP ALARMED FOR A SYSTEM ERROR 322- "LINK SWITCH ERROR (LOW)" IN THE ICU. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307062 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1