BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM IQ INFUSION PUMP

    MDR report key: 17279695 · Received July 7, 2023

    Report

    Report Number
    1314492-2023-02474
    Event Type
    Injury
    Date Received
    July 7, 2023
    Date of Event
    June 13, 2023
    Report Date
    December 4, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K222048
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    A SERVICE HISTORY REVIEW WAS PERFORMED AND REVEALED THAT THE DEVICE HAS NO PREVIOUS SERVICE EVENTS; THEREFORE, SERVICING DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. THIS EVENT IS POTENTIALLY RELATED TO THE ISSUES DESCRIBED IN FA 2021-056 ASSOCIATED WITH REINFORCING PROPER IV LINE SETUP TO PREVENT PARTIAL OR FULL OCCLUSIONS, AND DETECTION OF UPSTREAM OCCLUSION FOR SPECTRUM PUMPS, WHICH CAN LEAD TO UNDER-INFUSIONS. IF THE USER DOES NOT FULLY ADDRESS AN UPSTREAM OCCLUSION BEFORE RESTARTING THE INFUSION, THE PUMP'S ABILITY TO DETECT AN UPSTREAM OCCLUSION MAY BE REDUCED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SPECTRUM IQ PUMP DID NOT DELIVER MEDICATION AFTER AN UPSTREAM OCCLUSION. DURING AN INFUSION OF PROPOFOL FOR A TOTAL INTRAVENOUS ANESTHESIA (TIVA) THE DEVICE DID NOT ALARM AND NEVER INFUSED. THIS OCCURRED IN THE OPERATING ROOM. THE PATIENT "DID NOT RECEIVE THE MEDICATION DURING THE SURGERY AND THE PATIENT WAS AWAKE". NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422372 SPECTRUM IQ INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention PROPOFOL