BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2922746 · Received December 28, 2012

    Report

    Report Number
    1314492-2012-00558
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    December 2, 2012
    Report Date
    December 5, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING THE COMPLAINT EVAL, THE CUSTOMER STATED "PT IS STILL HOSPITALIZED DUE TO GLUCOSE LEVEL BUT THIS IS UNRELATED TO INCIDENT." SIGMA'S 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 FOR AN UPSTREAM OCCLUSION AND AIR IN LINE ALARM MANY TIMES DURING A PRIMARY INFUSION PROGRAMMED TO DELIVER INSULIN IN 100ML OF NACL 0.9% WITH 100 UNITS AT A RATE OF 1ML/HR. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1