BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3222012 · Received July 5, 2013

    Report

    Report Number
    1314492-2013-01034
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Date of Event
    June 1, 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
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. THE INVESTIGATION WAS ABLE TO REPRODUCE THE REPORTED SYMPTOM WHICH. HISTORY LOG REVIEW FOUND 4 OCCURRENCES OF EC 322. THE CAUSE OF THE REPORTED SYMPTOM WAS DETERMINED TO BE A FAILED UPPER LATCH SWITCH. THE UPPER AUXILIARY ASSEMBLY WILL BE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP ALARMS FOR SYSTEM ERROR 322. THE CUSTOMER ALSO STATED THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307120 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1