BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3063148 · Received February 27, 2013

    Report

    Report Number
    1314492-2013-00161
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 29, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. THE EVAL CONFIRMED THAT THE PUMP ALARMED FOR A SYSTEM ERROR 322 CAUSED BY A FAILED UPPER HOOK SWITCH. BAXTER'S ENGINEERING INVESTIGATION IS IN PROGRESS. WHEN COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP ALARMED AND SHUT OFF WHILE INFUSING DOPAMINE ON A PT (PROGRAMMED AMOUNT AND DELIVERY RATE UNK). IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY. THE CUSTOMER STATED THAT THE DEVICE PASSED PERFORMANCE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84541 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1