BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM IQ INFUSION PUMP

    MDR report key: 15057803 · Received July 19, 2022

    Report

    Report Number
    1314492-2022-03026
    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 UPSTREAM OCCLUSION NOT ALARMING WAS TESTED ON THE FLOW LINE WHICH RESULTED WITH ACCEPTABLE OCCLUSION TIMES AT SPECIFIC PRESSURE RANGES.THE EVENT HISTORY LOG REVIEW WAS PERFORMED AND REVEALED AN UPSTREAM OCCLUSION ALARM AT TIME 19:27 ON 23-JUNE-2022 AND THE PUMP CONTINUED UNTIL TIME 19:31. IT CANNOT BE DETERMINED IF THE LINE WAS ASSESSED FOR OR CLEARED OF AN UPSTREAM OCCLUSION THROUGH THE HISTORY LOG, HOWEVER PER NCR PR: 2236001/FA 2021-056, IF AN UPSTREAM OCCLUSION IN THE LINE IS NOT CLEARED AND THE PUMP RESUMED, A SUBSEQUENT ALARM MAY BE DELAYED OR MAY NOT OCCUR. 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. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED CONDITION WAS NOT VERIFIED. THE DEVICE WILL BE REQUIRED TO PASS ALL CALIBRATION AND TESTING PRIOR TO BEING RETURNED TO THE CUSTOMER. 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 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
    1434384 SPECTRUM IQ INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA 00085412610900

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown