BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM IQ INFUSION PUMP

    MDR report key: 15820419 · Received November 17, 2022

    Report

    Report Number
    1314492-2022-04992
    Event Type
    Injury
    Date Received
    November 17, 2022
    Report Date
    January 12, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412610900
    PMA / PMN Number
    K222048
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED AND DID NOT IDENTIFY ANY ISSUES RELATED TO THE CUSTOMER REPORTED CONDITION. THE EVALUATOR FOUND THE PUMP ABLE TO PROPERLY DETECT AN UPSTREAM OCCLUSION. THE ULTRASONIC SENSOR CALIBRATION WAS WITHIN RANGE. THE EVENT HISTORY LOG WAS REVIEWED AND THE EVENTS IN THE HISTORY LOG ALIGN WITH THE CUSTOMER REPORT. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE USER REPORTED THAT AN OCCLUSION WAS OBSERVED IN THE LINE. THE DEGREE OF THE OCCLUSION IS UNKNOWN, HOWEVER A PARTIAL OCCLUSION MAY NOT BE DETECTED BY THE PUMP OR THE PUMP MAY BE SLOW TO DETECT AN OCCLUSION. A DEFINITIVE CAUSE COULD NOT BE DETERMINED HOWEVER, THE ISSUE IS POTENTIALLY RELATED TO FA 2021-056, WHICH IS ASSOCIATED WITH REINFORCING PROPER IV LINE SETUP AND DETECTION OF UPSTREAM OCCLUSIONS FOR SPECTRUM PUMPS.THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PATIENT INFUSION OF LEVOPHED WITH A SPECTRUM IQ INFUSION PUMP, THE PATIENT EXPERIENCED HEMODYNAMIC INSTABILITY AND ¿A DROP IN PRESSURE¿. IT WAS FURTHER REPORTED THAT THE UPSTREAM TUBING BLOCKAGE WAS NOT DETECTED DURING THE INFUSION AND THE FLOW RATE WAS INCREASED UNTIL THE OBSTRUCTION WAS DETECTED. ACCORDING TO THE REPORTER, THE ¿HEMODYNAMIC INSTABILITY OF THE PATIENT REQUIRED IMMEDIATE MEDICAL INTERVENTION AND CLOSE MONITORING OF THE CLINICAL CONDITION¿. THE PATIENT REMAINED UNSTABLE UNTIL THE CORRECT FLOW OF LEVOPHED FLOW WAS ACHIEVED BY TITRATING THE INFUSION ¿UPWARDS¿. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2768756 SPECTRUM IQ INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA 00085412610900

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention UNKNOWN ACCESS SET