BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM IQ INFUSION PUMP

    MDR report key: 16666133 · Received April 3, 2023

    Report

    Report Number
    1314492-2023-01135
    Event Type
    Malfunction
    Date Received
    April 3, 2023
    Date of Event
    March 10, 2023
    Report Date
    June 27, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412610900
    PMA / PMN Number
    K222048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION H6:MEDICAL DEVICE PROBLEM CODE CORRECTED TO A090102. THE DEVICE WAS RECEIVED FOR EVALUATION. DURING FUNCTIONAL TESTING, THE SPEAKER WAS QUIET. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE A FAILED REAR CASE. THE REAR CASE REQUIRES REPLACEMENT TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SPEAKER OF SPECTRUM IQ PUMP WAS QUIET. THIS OCCURRED 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
    1116230 SPECTRUM IQ INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA 00085412610900

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown