BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM IQ INFUSION PUMP

    MDR report key: 14453152 · Received May 20, 2022

    Report

    Report Number
    1314492-2022-01971
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    November 16, 2021
    Report Date
    June 7, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K173084
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER FACILITY SUBMITTED MEDWATCH MW5108364 FOR THIS EVENT. THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED ADDITIONAL INFORMATION H10: THIS REPORTED PROBLEM IS POTENTIALLY WITHIN SCOPE OF FA 2021-056: SPECTRUM IQ (V9) AND V8 - DEVICE SAFETY SIGNAL FOR NON-DELIVERY AND UNDETECTED UPSTREAM OCCLUSION. BAXTER IS COMMUNICATING IMPORTANT SAFETY INFORMATION FOR SPECTRUM V8 AND SPECTRUM IQ INFUSION PUMPS RELATED TO POTENTIAL REDUCED OR NON-DELIVERY OF MEDICATION, IN SOME CASES WITHOUT ALERTING THE USER VIA PUMP ALARM. THIS MAY OCCUR AS A RESULT OF INCORRECT ADMINISTRATION SET SETUP AND/OR INCOMPLETE RESOLUTION OF UPSTREAM OCCLUSION ALARMS WHEN USING SPECTRUM V8 AND SPECTRUM IQ INFUSION PUMPS. AS DESCRIBED IN THE INSTRUCTIONS FOR USE (IFU), IT IS IMPERATIVE TO FULLY RESOLVE ANY UPSTREAM OCCLUSION BEFORE RESTARTING THE PUMP AFTER AN UPSTREAM OCCLUSION ALARM. 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 HEPARIN WITH A SPECTRUM IQ PUMP, THE PUMP WAS NOT INFUSING THE MEDICATION, SPECIFIED AS THE ¿DRIPS WERE NOT FALLING INTO THE CHAMBER¿. THE BAG OF MEDICATION WAS SUPPOSED TO HAVE 30 ML REMAINING; HOWEVER, THE BAG WAS FULL. THE PATIENT¿S OXYGENATION STATUS ¿ACUTELY CHANGED¿ WHICH REQUIRED INCREASES IN FRACTION OF INSPIRED OXYGEN (FI02), POSITIVE END-EXPIRATORY PRESSURE (PEEP) AND AN ¿EMERGENT PRONE". THE REPORTER STATED THE HEPARIN LEVELS WERE SUBTHERAPEUTIC. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2450712 SPECTRUM IQ INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention HEPARIN.