BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUANTUM 12" ELITE WORKSTATION

    MDR report key: 16245369 · Received January 26, 2023

    Report

    Report Number
    3006073153-2023-00001
    Event Type
    Death
    Date Received
    January 26, 2023
    Date of Event
    December 31, 2022
    Report Date
    January 26, 2023
    Manufacturer
    SPECTRUM MEDICAL LTD
    Product Code
    DRY
    UDI-DI
    05060434421852
    PMA / PMN Number
    K202557
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FLOW PROBE SENSOR, ECMO COORDINATOR, REPORTED THAT THEY HAD A 1/4" FLOW PROBE THAT WAS READING ABOUT HALF OF THE ACTUAL FLOW. THE FLOW PROBE FS2000138 WAS THE ARTERIAL FLOW PROBE, AND THE ENTIRE CASE IT WAS READING AROUND .200 LPM, WHICH WAS THE TARGET FLOW THEY ALSO HAD A VENOUS FLOW PROBE (MEASURED PRE-SHUNT SO THISSHOULD BE VERY CLOSE TO THE ART FLOW) AND AN "ALT FLOW" PROBE (SHUNT FLOW). AN ECMO SPECIALIST EVENTUALLY NOTICED THE DISCREPANCY BETWEEN ART AND VEN FLOWS (NO ALARMS SET OR CHARTING OF VEN AND ALT ROUTINELY). THEY DID SOME TROUBLE SHOOTING BY ATTACHING ALL FLOW PROBES TO THE ARTERIAL LINE, AND THE ART FLOW WAS READING ABOUT HALF OF WHAT THE OTHER TWO FLOW PROBES WERE READING. THEY THEN REPLACED FS2000138 WITH A NEW FLOW PROBE, AND THIS WAS READING THE SAME AS THE VENOUS FLOW PROBE. THE SPECIALIST THAT SET UP THE PUMP REPORTED ZEROING ALL FLOWS BEFORE THE CASE. THEY DID NOT ZERO THE REPLACEMENT FLOW PROBE BECAUSE THEY WERE ON SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855944 QUANTUM 12" ELITE WORKSTATION BLOOD GAS MONITOR DRY SPECTRUM MEDICAL LTD QFS 3/8 X 2.0M (ID 1/4" X WALL 1/16") 05060434421852

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA Unknown Death| C