BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2973487 · Received February 14, 2013

    Report

    Report Number
    1314492-2013-00103
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 18, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. AT THIS TIME, THE DATE OF EVENT IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP WAS PROGRAMMED TO DELIVER NEOSYNEPHRINE TO A PT (PROGRAMMED AMT AND DELIVERY RATE UNK). THE CUSTOMER REPORTED THAT THE PT'S BLOOD PRESSURE CONTINUED TO DROP. THE MEDICATION WAS "TITRATED PER PROTOCOL" AND THE PT'S BLOOD PRESSURE CONTINUED TO DROP. THE NURSE OBSERVED THAT THE IV SLIDE CLAMP DISTAL TO THE PUMP WAS CLOSED. THE CUSTOMER STATED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66293 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention