BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM IQ INFUSION PUMP

    MDR report key: 15013278 · Received July 14, 2022

    Report

    Report Number
    1314492-2022-02934
    Event Type
    Injury
    Date Received
    July 14, 2022
    Date of Event
    December 14, 2021
    Report Date
    July 14, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K220417
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION/REMOVAL NUMBER: FA-2021-056. THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. THE CUSTOMER REPORTED THAT THERE WAS A KINK IN THE IV SET, BUT DID NOT EXPERIENCE AN UPSTREAM OCCLUSION ALARM. THERE IS CURRENTLY AN OPEN FIELD ACTION (FA-2021-056) ASSOCIATED WITH REINFORCING PROPER IV LINE SETUP AND DETECTION OF UPSTREAM OCCLUSION FOR SPECTRUM PUMPS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED HYPOTENSION DURING VASOPRESSOR THERAPY USING A SPECTRUM PUMP. THE PUMP FAILED TO DETECT AN UPSTREAM OCCLUSION EVEN THOUGH THE TUBING WAS OBSERVED TO HAVE A KINK. THE INFUSION RATE WAS INITIATED AT 16.9 ML AND THE ISSUE WAS OBSERVED WHEN THE NURSE NEEDED TO TITRATE THE DOSE TO 75CC/HR OVER A PERIOD OF 18 MINUTES. THE PATIENT EXPERIENCED A PROFOUND HYPOTENSION DUE TO NOT RECEIVING THE VASOPRESSORS MEDICATION. THE NURSE HAD TO SET UP WITH A NEW PUMP AND NEW TUBING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2284469 SPECTRUM IQ INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention CLEARLINK SYSTEM CONTINU-FLO