BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM IQ INFUSION PUMP

    MDR report key: 15361549 · Received September 6, 2022

    Report

    Report Number
    1314492-2022-03809
    Event Type
    Malfunction
    Date Received
    September 6, 2022
    Date of Event
    August 10, 2022
    Report Date
    September 6, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412610900
    PMA / PMN Number
    K220417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION. DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED A WHITE SCREEN AT POWER UP. 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 VERIFIED. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE A FAULTY PROCESSOR BOARD. THE PROCESSOR BOARD WILL REQUIRE REPLACEMENT TO CORRECT THE ISSUE. THIS DEVICE IS ASSOCIATED WITH FA-2020-056 TO PERFORM SOFTWARE UPGRADE AND THE DEVICE SOFTWARE WILL BE UPDATED. 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 PUMP DISPLAYED A WHITE SCREEN DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2368954 SPECTRUM IQ INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA 00085412610900

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown