BEUDAMED
    FDA Adverse Event Death Summary report: N

    MC3

    MDR report key: 21136531 · Received January 13, 2025

    Report

    Report Number
    3011468686-2025-00002
    Event Type
    Death
    Date Received
    January 13, 2025
    Date of Event
    April 11, 2024
    Report Date
    January 13, 2025
    Manufacturer
    MC3 INC.
    Product Code
    PZS
    PMA / PMN Number
    K180151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 70128 (UNKNOWN SERIAL/LOT); PRODUCT TYPE: 0183-CANNULA; PRODUCT ID 70124 (UNKNOWN SERIAL/LOT); PRODUCT TYPE: 0183-CANNULA; PRODUCT ID 70128 (UNKNOWN SERIAL/LOT); PRODUCT TYPE: 0183-CANNULA; PRODUCT ID 70124 (UNKNOWN SERIAL/LOT); PRODUCT TYPE: 0183-CANNULA; PRODUCT ID 70128 (UNKNOWN SERIAL/LOT); PRODUCT TYPE: 0183-CANNULA. G2: CITATION: AUTHORS: ARMIN-KAI SCHOEBERL, DAWID STAUDACHER, MITSUAKI KAWASHIMA. ALTERNATIVE VENOUS ACCESS SITES FOR DUAL-LUMEN EXTRACORPOREAL MEMBRANE OXYGENATION CANNULATION. INTERDISCIPLINARY CARDIOVASCULAR AND THORACIC SURGERY 38(4) 2024. 10.1093/ICVTS/IVAE060 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING SINGLE-SITE CANNULATION USING AN ALTERNATIVE VENOUS ACCESS SITES FOR DUAL-LUMEN EXTRACORPOREAL MEMBRANE OXYGENATION CANNULATION. THE TIME FRAME OF THIS STUDY WAS JANUARY 2011 AND APRIL 2022. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: MC3 CRESCENT DUAL-LUMEN CANNULAE (24 FR AND 28 FR). DEATHS OCCURRED IN THE STUDY POPULATION. THE CAUSES OF DEATH WERE FAILURE TO RECOVER AND WITHDRAWAL OF THERAPY, MULTI- ORGAN FAILURE, PATIENT WILL, ANOXIC BRAIN INJURY, UNCLEAR CEREBRAL OEDEMA AND HAEMORRHAGIC SHOCK AFTER A LIVER BIOPSY. AMONG PATIENT ADVERSE EVENTS INCLUDED: BLEEDING AT THE CANNULATION SITE THAT EVENTUALLY REQUIRED BLOOD TRANSFUSION AND WAS MANAGED BY ADAPTING THE HEPARIN DOSAGE. ONE PATIENT SUFFERED FROM RECURRING ¿SUCK DOWN¿ EPISODES OF THE ECMO CANNULA, WHICH WAS MANAGED WITH CONTINUOUS VOLUME ADMINISTRATION. THE CANNULA WAS FIRST REPOSITIONED AND ULTIMATELY CHANGED TO A FEMORAL-JUGULAR CONFIGURATION. UNFORTUNATELY, THIS DID NOT REDUCE THE FREQUENCY OF ¿SUCK DOWN¿ EPISODES AND THE PATIENT HAD TO FURTHER BE MANAGED WITH ADDITIONAL VOLUME ADMINISTRATION. PRODUCT MALFUNCTIONS INCLUDED: CHANGE OF ECMO CONFIGURATION AND REPOSITIONING OF THE CANNULAE. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567291 MC3 DUAL LUMEN ECMO CANNULA PZS MC3 INC. 70124

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Death