BEUDAMED
    FDA Adverse Event Death Summary report: N

    MC3 CRESCENT RA DUAL LUMEN CATHETER 15FR

    MDR report key: 14840581 · Received June 28, 2022

    Report

    Report Number
    14840581
    Event Type
    Death
    Date Received
    June 28, 2022
    Date of Event
    February 25, 2022
    Report Date
    June 20, 2022
    Manufacturer
    MICHIGAN CRITICAL CARE CONSULTANTS, INC.
    Product Code
    PZS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PERICARDIAL EFFUSION WHICH REQUIRED A PERICARDIAL DRAIN PLACED. THIS PATIENT WAS ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT AND WAS CANNULATED WITH A MC3 CRESCENT RA DUAL LUMEN CATHETER 15FR. NOTES FROM CARDIOVASCULAR RECORDS. PATIENT HAD A HISTORY OF PULMONARY VALVE STENOSIS. EPISODES OF HYPOTENSION SECONDARY TO FENTANYL DRIPS. SEVERAL EPISODES OF BRADYCARDIA WITH HYPOXIA, INITIALLY IMPROVED ONCE ADEQUATE VENTILATION OBTAINED, BUT THEN BRADYCARDIA PERSISTED. FIRST CODE EVENT DUE TO HYPOXIC BRADYCARDIC ARREST, REQUIRING COMPRESSIONS, ROCURONIUM, EPI-SPRITZER, ATROPINE. CARDIOLOGY CONSULTED GIVEN PERSISTENT BRADYCARDIA AND CODE EVENT. ECHO OBTAINED SHOWED SMALL PERICARDIAL EFFUSION, MILD TRICUSPID VALVE REGURGITATION (PEAK GRADIENT OF 18 MMHG), NORMAL RIGHT VENTRICULAR SIZE AND QUALITATIVELY NORMAL SYSTOLIC FUNCTION, AND NORMAL LEFT VENTRICULAR SIZE AND QUALITATIVELY NORMAL SYSTOLIC FUNCTION. REPEAT ECHOCARDIOGRAM WITH SMALL ANTERIOR PERICARDIAL EFFUSION BUT WITHOUT EVIDENCE OF PULMONARY HTN. EKG OBTAINED SHOWED SINUS RHYTHM. WITH PROGRESSIVE DIFFICULTY OXYGENATING, PATIENT WAS PLACED ON VENO-VENOUS (VV) ECMO. ECHO OBTAINED AFTER CANNULATION SHOWED NORMAL FUNCTION, TIP OF VV ECMO NEAR/AT BACK WALL OF RIGHT ATRIUM (RA) WITH FLOW DIRECTED TOWARDS TRICUSPID VALVE, AND SMALL PERICARDIAL EFFUSION. FOLLOWING INITIATION OF VV ECMO, THE PATIENT'S HEMODYNAMICS WERE OVERALL REASSURING. ON THE DAY PRECEDING HER DEATH, PATIENT HAD REASSURING HEART RATE AND BLOOD PRESSURE WAS ABLE TO DIURESE. HOWEVER A FEW MINUTES PRIOR TO HER CODE EVENT, THE PATIENT WAS NOTED TO BE TACHYCARDIC AND HYPOTENSIVE. VOLUME RESUSCITATION WAS INITIATED. IT WAS THEN NOTED THAT THE PATIENT HAD A NARROW PULSE PRESSURE APULSES PARADOXUS. THE PATIENT WENT INTO PULSELESS ELECTRIC ACTIVITY (PEA). CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED AND A PERICARDIAL TAMPONADE WAS DIAGNOSED. PERICARDIAL TAMPONADE WAS DRAINED BUT CONTINUED TO HAVE MASSIVE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909733 MC3 CRESCENT RA DUAL LUMEN CATHETER 15FR DUAL LUMEN ECMO CANNULA PZS MICHIGAN CRITICAL CARE CONSULTANTS, INC. 70415

    Patients

    Seq Age Sex Outcome Treatment
    1 600 DA Female Death