BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3191175 · Received June 14, 2013

    Report

    Report Number
    1314492-2013-00789
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 17, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER FOR EVALUATION. EVALUATION CONFIRMED THE REPORTED SYMPTOM. FURTHER EVALUATION IDENTIFIED THAT THE ABSENCE OF AUDIO WAS DUE TO A FAILED SPEAKER. ALL DETECTION CAPABILITIES AND FUNCTIONS PERFORMED AS EXPECTED. THE DEVICE WAS DETERMINED NOT TO BE WITHIN SPECIFICATION IN RELATION TO THE REPORTED SYMPTOM. THE SPEAKER WAS REPLACED AND THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP HAS NO AUDIO FUNCTION. THE CUSTOMER STATED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272344 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1