BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM IQ

    MDR report key: 15120792 · Received July 28, 2022

    Report

    Report Number
    15120792
    Event Type
    Malfunction
    Date Received
    July 28, 2022
    Date of Event
    July 25, 2022
    Report Date
    July 27, 2022
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT UNDERGOING CABG IN SPOR 20 AT 7:30AM. AFTER INDUCTION AND PLACEMENT OF CENTRAL LINES, 250ML INFUSION WITH 250MCG OF SUFENTANIL AND 5 MG OF MIDAZOLAM WAS STARTED AT 100 ML/HR ON SIGMA PUMP Y024038. NO ALARMS WERE NOTED ON THE PUMP. DURING THE PRE-BYPASS STAGE OF THE PROCEDURE, VERY DIFFICULT TO CONTROL HYPERTENSION WAS NOTED, WITH SYSTOLIC REACHING 180MMHG. ULTIMATELY, THE PATIENT REACHED STABLE HEMODYNAMICS WITH 3 MCG/KG/MIN OF NITROGLYCERINE AND 2.5 MG/HR OF NICARDIPINE ON TOP OF 0.7-1.0 MAC OF SEVOFLURANE AND THE SUFENTANIL/MIDAZOLAM INFUSION. WHEN THE VTBI ALARM SOUNDED APPROXIMATELY 2.5 HOURS AFTER STARTING THE INFUSION (THE PATIENT WAS NOW UNDER CARDIOPULMONARY BYPASS), IT WAS NOTED THAT ONLY ~75 ML OF THE INTENDED 250 ML HAD BEEN INFUSED. THE PUMP WAS REPLACED. THE PATIENT IS STILL UNDERGOING SURGERY, BUT INTRAOPERATIVE AWARENESS WILL BE ASSESSED POSTOPERATIVELY. MANUFACTURER RESPONSE FOR IV PUMP, IV PUMP (PER SITE REPORTER) ONGOING ISSUE WITH BAXTER PUMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2925188 SPECTRUM IQ PUMP, INFUSION FRN BAXTER INTERNATIONAL INC. 3570009

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown