BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRESCENT JUGULAR DUAL LUMEN CATHETER 32FR

    MDR report key: 13518200 · Received February 11, 2022

    Report

    Report Number
    3011468686-2022-00002
    Event Type
    Death
    Date Received
    February 11, 2022
    Date of Event
    January 12, 2022
    Report Date
    February 11, 2022
    Manufacturer
    MC3 INC.
    Product Code
    PZS
    PMA / PMN Number
    K180151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT CATHETER HAS NOT BEEN RETURNED FOR EVALUATION. THE DHR REVIEW DID NOT REVEAL ANY ISSUES DURING MANUFACTURING OF THE LOTS.

    Description of Event or Problem · 0

    MC3 RECEIVED INFORMATION THAT DURING VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (VV-ECMO) FOR A TRANSPLANT PATIENT, THE MC3 CRESCENT JUGULAR DUAL LUMEN CATHETER FRACTURED AFTER 42 DAYS OF USE, AND AIR WAS DETECTED. CATHETER HAD BEEN PLACED VIA THE RIGHT INTERNAL JUGULAR VEIN WITH A 20 FR DACRON GRAFT. CATHETER FRACTURED ABOVE DACRON GRAFT. THE CUSTOMER OBSERVED INTERMITTENT AIR IN CIRCUIT AND THEY PERFORMED A CIRCUIT EXCHANGE. AFTER THE CIRCTUIT CHANGE, AIR WAS NOTICED COMING FROM THE CANNULA AND IT ENTERED THE CIRCUIT. THE CUSTOMER STATED THAT THEY COULD NOT SLOW DOWN THE PUMP OR GO ON VA ECMO. THE CUSTOMER STATED THAT THE LUNG HAD LITTLE RESERVE. THE PATIENT DID NOT SURVIVE. IT WAS STATED THAT THE PATIENT DIED OF HYPOXIC RESPIRATORY FAILURE. THIS EVENT IS ALSO REPORTED BY THE HOSPITAL. MEDWATCH REPORT 010033-2022-0001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883806 CRESCENT JUGULAR DUAL LUMEN CATHETER 32FR DUAL LUMEN CATHETER 32FR PZS MC3 INC. 70132 2110149

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Death