BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM IQ INFUSION PUMP

    MDR report key: 12548344 · Received September 29, 2021

    Report

    Report Number
    1314492-2021-03705
    Event Type
    Injury
    Date Received
    September 29, 2021
    Date of Event
    August 30, 2021
    Report Date
    October 29, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412610900
    PMA / PMN Number
    K173084
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE DEVICE WAS TESTED FOR FLOW ACCURACY AT THE CUSTOMER REPORTED EVENT RATE AND FOUND TO DELIVER WITHIN INTENDED RANGE. THERE ARE NO EVENTS RECORDED IN THE HISTORY LOG MATCHING THE CUSTOMER REPORTED PARAMETERS: 21 ML/HR AND/OR 590 ML/HR ON THE REPORTED EVENT DATE OR ON ANY OTHER DATE IN THE LOG. THE REPORTED EVENTS WERE NOT OBSERVED IN THE LOG, AND NO ABNORMALITIES THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM WERE OBSERVED THROUGH THE HISTORY LOG. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY ISSUES DURING MANUFACTURING OF THE DEVICE THAT MAY BE RELATED TO THE CURRENT COMPLAINT. A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE REPORTED CONDITION WAS NOT VERIFIED. NO PUMP CORRECTION IS REQUIRED. PUMP SET UP, THE SPECIFIC IV SET USED, AND ENVIRONMENTAL CONDITIONS FOR THIS SPECIFIC EVENT ARE UNKNOWN, HOWEVER MEMBERS OF THE BAXTER CLINICAL SERVICES TEAM VISITED THE CUSTOMER FACILITY AND OBSERVED A NUMBER OF ISSUES RELATED TO SETUP THAT MAY IMPACT FLOW. THE CLINICAL SERVICES TEAM MET WITH INTENSIVE CARE UNIT NURSING STAFF AT THE FACILITY TO DISCUSS DUO VENT PRIMING AND PROPER SPIKING OF A RIGID CONTAINER AND BAGS, SPECIFICALLY. THE SPECTRUM IQ OPERATOR'S MANUAL CAUTIONS, "THE UPSTREAM OCCLUSION DETECTOR MAY NOT DETECT PARTIALLY OCCLUDED TUBING. ALWAYS CHECK TO ENSURE THE IV SET¿S CLAMP IS NOT CLOSED ABOVE THE PUMP AND RESPOND APPROPRIATELY TO ALL PRIMARY AND SECONDARY CHECK FLOW PROMPTS." THE PUMP'S DOSE ERROR REDUCTION SYSTEM (DERS) IS DESCRIBED AND INCLUDES A PRIMARY FLOW CHECK FOR ERROR PREVENTION. A SCREEN DISPLAYS AT THE START OF THE INFUSION AND THE CLINICIAN MUST MAKE SURE THAT: ALL CLAMPS ARE OPEN, THERE ARE NO KINKS IN THE TUBING THAT MIGHT PREVENT FLOW, AND DROPS ARE FLOWING IN THE DRIP CHAMBER. THE SCREEN REQUIRES USER RESPONSE VIA A KEY PRESS. THE SPECIFIC IV SET USED WAS NOT IDENTIFIED BY THE CUSTOMER, HOWEVER THE FOLLOWING WARNINGS MAY BE FOUND IN THE COMPATIBLE BAXTER IV SETS LIST: "PARTIALLY OCCLUDED FILTERS CAN CAUSE AIR-IN-LINE, UPSTREAM OCCLUSION OR DOWNSTREAM OCCLUSION ALARMS OR NEGATIVELY AFFECT FLOW RATE ACCURACY." AND "RIGID UNVENTED CONTAINERS USED WITH UNVENTED SETS OR VENTED SETS WITH VENT CLOSED, WILL CAUSE UPSTREAM OCCLUSIONS THAT MAY NOT BE DETECTED BY THE INFUSION PUMP." SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY SUBMITTED MEDWATCH 5103734 FOR THIS EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CONTINUOUS INFUSION OF NOREPINEPHRINE (0.02MCG/KG/MIN) WITH A SPECTRUM IQ PUMP, THE PATIENT EXPERIENCED A SUDDEN DROP IN BLOOD PRESSURE. AS A RESULT, THE INFUSION WAS ADJUSTED MULTIPLE TIMES THEN INCREASED TO THE MAXIMUM DOSE OF 3MCG/KG/MIN AT 590MLS/HR. IT WAS REPORTED THE BLOOD PRESSURE REMAINED "IN LOW PARAMETER". ADDITIONAL MEDICATION WAS INITIATED (VASOPRESSIN) WHICH RESULTED IN THE BLOOD PRESSURE "RESPONDING WELL". IT WAS REPORTED THE PUMP WAS NOT INFUSING AND DID NOT ALARM; HOWEVER, CONTINUED TO RUN WITHOUT ANY MEDICATION BEING INFUSED. IT WAS REPORTED THE PATIENT WAS RESUSCITATED AND SUBSEQUENTLY WAS ABLE TO TRANSFER OUT OF THE INTENSIVE CARE UNIT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1443365 SPECTRUM IQ INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA 00085412610900

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention