BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM IQ INFUSION PUMP

    MDR report key: 18133693 · Received November 14, 2023

    Report

    Report Number
    1314492-2023-04230
    Event Type
    Injury
    Date Received
    November 14, 2023
    Report Date
    December 13, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K222048
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. 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 NCR PR: 2236001/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 WHILE INTRAVENOUS FLUIDS WERE RUNNING AT 100 ML/HOUR ON A SPECTRUM IQ INFUSION PUMP, IT FAILED TO ALARM UPSTREAM OCCLUSION. IT WAS FURTHER REPORTED THAT THE BLUE SLIDE CLAMP WAS OBSERVED TO HAVE BEEN CLAMPED OFF AFTER THE START OF THE INFUSION (DURATION UNKNOWN) AND THE PUMP DID NOT ALARM AS EXPECTED. ACCORDING TO THE REPORTER, THE PATIENT BECAME HYPOTENSIVE ("PATIENT'S BLOOD PRESSURE BOTTOMED"); HOWEVER, CURRENTLY THE PATIENT "BECAME STABLE". NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1989966 SPECTRUM IQ INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other