BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2992824 · Received February 28, 2013

    Report

    Report Number
    1314492-2013-00176
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 30, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER FOR EVAL AND THEREFORE, AN EVAL COULD NOT BE COMPLETED. IF THE DEVICE IS RETURNED, AN EVAL WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP WAS UNABLE TO DELIVER FLUID TO A PT. THE DEVICE WAS PROGRAMMED TO DELIVER A VASOPRESSOR/INOTROP AT A RATE OF 13.6 ML/HR. TWO IV EXTENSION SETS (APPROX 200 INCHES) WERE ADDED TO THE END OF THE PRIMARY IV SET. THE CUSTOMER STATED THAT THE PT'S BLOOD PRESSURE DROPPED CRITICALLY LOW AND REQUIRED MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87250 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BAXTER IV SET 1C8657| BAXTER IV SET 2C8612