BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM IQ

    MDR report key: 20106548 · Received August 30, 2024

    Report

    Report Number
    1314492-2024-02812
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Report Date
    August 30, 2024
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    FRN
    PMA / PMN Number
    K222048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER PHONE NO: (B)(6). THE DEVICE WAS RECEIVED FOR EVALUATION. DURING EVALUATION, THE REPORTED PROBLEM OF 'FAILED DS OCC TEST, 22 PSI' WAS NOT REPRODUCED. A SERVICE HISTORY REVIEW WAS PERFORMED AND REVEALED THAT THE DEVICE HAS NO PREVIOUS SERVICE EVENTS; THEREFORE, SERVICING DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE REPORTED CONDITION WAS NOT VERIFIED. THE FORCE SENSOR WILL REQUIRE CALIBRATION PER SERVICE PROCEDURE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SPECTRUM IQ INFUSION PUMP FAILED DOWNSTREAM OCCLUSION TEST. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF 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
    1793972 SPECTRUM IQ PUMP, INFUSION FRN BAXTER INTERNATIONAL INC. 3570009 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown