BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM IQ INFUSION PUMP

    MDR report key: 15057953 · Received July 19, 2022

    Report

    Report Number
    1314492-2022-03027
    Event Type
    Malfunction
    Date Received
    July 19, 2022
    Report Date
    July 19, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412610900
    PMA / PMN Number
    K220417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION. DURING FUNCTIONAL TESTING, NOT ALARMING FOR UPSTREAM OCCLUSION DID NOT OCCUR. A REVIEW OF THE EVENT HISTORY LOG REVEALED THE LAST "UPSTREAM OCCLUSION!" ALARM IS RECORDED IN THE HISTORY LOG ON 23-JUNE-2022. THE EVENT IS POTENTIALLY RELATED TO THE ISSUE DESCRIBED BY FA 2021-056. 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. BASED ON THE RESULTS OF THE SAMPLE ANALYSIS, THE REPORTED PROBLEM WAS NOT DUE TO DEVICE MALFUNCTION OF THE SPECTRUM INFUSION PUMP; HOWEVER, IT CANNOT BE DEFINITIVELY CONFIRMED IF USE ERROR CAUSED OR CONTRIBUTED TO THE EVENT. THERE IS CURRENTLY AN OPEN FIELD ACTION (FA-2021-056) ASSOCIATED WITH REINFORCING PROPER IV LINE SETUP AND DETECTION OF UPSTREAM OCCLUSION FOR SPECTRUM PUMPS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SPECTRUM IQ PUMP DID NOT ALARM AN UPSTREAM OCCLUSION DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240965 SPECTRUM IQ INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA 00085412610900

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown