BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM IQ INFUSION PUMP

    MDR report key: 11942699 · Received June 4, 2021

    Report

    Report Number
    1314492-2021-02107
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Report Date
    July 29, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412610900
    PMA / PMN Number
    K173084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B4/F8: DATE OF THIS REPORT IN THE INITIAL MDR IS BEING CORRECTED FROM BLANK TO 06/04/2021.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION H3, H6 AND H10: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED AUTO DOSE CHANGE. A SERVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE WAS FOUND TO BE WITHIN SPECIFICATION DURING TESTING. THE REPORTED CONDITION WAS NOT VERIFIED. TROUBLESHOOTING THE DEVICE REVEALED NO HARDWARE/SOFTWARE ABNORMALITIES THAT WOULD INDUCE THE REPORTED ALLEGATION. NO CORRECTION IS REQUIRED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE WAS RECEIVED, AND AN EVALUATION IS COMPLETE. EVALUATION INCLUDED A VISUAL ASSESSMENT AS WELL AS FUNCTIONAL TESTING. A SERVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. EVALUATION EXPERIENCED A FAILED FLOW ACCURACY DURING TESTING. THE CAUSE WAS IDENTIFIED TO BE AN OUT OF ADJUSTMENT PRESSURE PLATE TRAVEL WHICH WAS ADJUSTED TO CORRECT THIS CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM IQ PUMP DOSE WAS CHANGED FROM 2 G/HR TO 1 G/HR (MEDICATION UNKNOWN), AND THE FOLLOWING SHIFT NOTICED THAT THE PUMP WAS INFUSING AT 21G/HR. THE EVENT HAPPENED DURING PATIENT INFUSION IN THE GENERAL PATIENT WARD. THERE WAS NO KNOWN PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834785 SPECTRUM IQ INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA 00085412610900

    Patients

    Seq Age Sex Outcome Treatment
    1