BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3071285 · Received April 9, 2013

    Report

    Report Number
    1314492-2013-00371
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF NO.: (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED THE DEVICE IN QUESTION. REVIEW OF THE DEVICE HISTORY LOG CONFIRMS THAT THE PUMP ALARMED MULTIPLE TIMES FOR AN UPSTREAM OCCLUSION. THE EVALUATION COULD NOT REPRODUCE A CONSTANT UPSTREAM OCCLUSION ALARM. THE DEVICE WAS TESTED FOR 24 HOURS AND THE DEVICE PERFORMED AS EXPECTED. UPSTREAM OCCLUSION/AIR SENSOR TESTING WAS PERFORMED WITH THE UNIT PASSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE INFUSION SET UP, A PUMP ALARMED CONSTANTLY FOR AN UPSTREAM OCCLUSION. THE EVENT OCCURRED IN THE SAME DAY SURGERY UNIT AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147893 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1