BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAUTILUS SMART ECMO MODULE

    MDR report key: 14595615 · Received June 3, 2022

    Report

    Report Number
    3011468686-2022-00007
    Event Type
    Injury
    Date Received
    June 3, 2022
    Date of Event
    March 29, 2022
    Report Date
    June 3, 2022
    Manufacturer
    MC3 INC.
    Product Code
    BYS
    UDI-DI
    10854916006871
    PMA / PMN Number
    K191935
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS NOT RETURNED SO THAT A DEFINITE CAUSE COULD NOT BE CONFIRMED. THE SUSPECTED CAUSE OF INCREASED PRESSURE DROP IS THROMBUS FORMATION WITHIN THE DEVICE. THE CUSTOMER DID NOT REPORT AN ALLEGED PRODUCT ISSUE. THIS MDR IS REPORTED AS RELATED TO THE USER MEDWATCH REPORT. THE PRODUCTION RECORD OF THE SPECIFIC DEVICE WAS REVIEWED AND REVEALED NO CONCERNS. REVIEW OF THE CUSTOMER STATEMENTS SUGGESTS THAT THERE MAY HAVE BEEN BLOOD CLOTTING WITHIN THE DEVICE DURING THE INITIAL 2 HOURS OF USE. THE DEVICE EXCHANGE OCCURRED WITHOUT INCIDENT. THE ANTICOAGULANT USED WAS BIVALIRDUDIN AFTER PREVIOUS USE OF HEPARIN WITH PTT MONITORING DURING ECMO. CLINICAL FACTORS RELATED TO BLOOD COAGULATION OR PATIENT CONDITIONS COULD NOT BE FURTHER EVALUATED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT FOR ADDITIONAL INFORMATION IN B1(ADVERSE EVENT) AND (REQUIRED INTERVENTION...). CORRECTIONS TO (UDI), (CONTACT INFORMATION), AND (CHANGE FROM MALFUNCTION TO SERIOUS INJURY).

    Description of Event or Problem · 0

    MC3 RECEIVED A NOTIFICATION FROM FDA REGARDING MEDWATCH REPORT # MW5108862. URGENT OXYGENATOR CHANGE OUT DUE TO INCREASE DELTA P. FLOWS DROPPED GRADUALLY TO 3 L/MIN CONCURRENT WITH AN INCREASE IN DELTA PRESSURE UP TO 160 MMHG. THE ORIGINAL NAUTILUS SMART OXY WAS REPLACED IN THE NEW NAUTILUS SMART WITHOUT INCIDENT. DR. WAS BEDSIDE FOR THE PROCEDURE. THERE WAS NO REPORTED IMPACT ON THE PATIENT. ADDITIONAL INFORMATION GATHERED FROM UPMC BY THE DISTRIBUTOR'S CLINICAL PERFUSIST REPRESENTATIVE INCLUDED THE FOLLOWING: THE PATIENT WAS TREATED WITH HEPARIN PRIOR TO INITIATION OF ECMO. THERE WAS NO ANTICOAGULANT IN THE PRIME SOLUTION. BIVALIRDUDIN WAS MONITORED WITH PTT. THE PATIENT HCT WAS 27.6. A CMAG PUMP AND TERUMO CIRCUIT WITH X COATED TUBING WAS ALSO UTILIZED FOR THIS CASE. TIME ON DEVICE WAS 2 HOURS PRIOR TO OXYGENATOR DEVICE EXCHANGE. THE PERFUSION RECORD MEASUREMENTS RECORDED WERE TEMP 37 C, FLOW 3 LPM, SWEEP 2, PTT 125, PRE-PRESS 240, POST-PRESS 80, FIO2 1.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1800472 NAUTILUS SMART ECMO MODULE ECMO OXYGENATOR BYS MC3 INC. 48135 2109116 10854916006871

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention