BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL LUMEN 31 FR RA TO PA ECMO CANNULA

    MDR report key: 14512702 · Received May 26, 2022

    Report

    Report Number
    14512702
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    May 19, 2022
    Report Date
    May 25, 2022
    Manufacturer
    SPECTRUM MEDICAL INC
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    SPECTRUM DUAL LUMEN RA (RIGHT ATRIUM) TO PA (PULMONARY ARTERY) CANNULA SEPARATED AT A JUNCTION AND ALLOWED AIR TO ENTRAIN INTO THE EXTRACORPOREAL CIRCUIT AND TO THE PATIENT'S VENOUS SYSTEM. RIGHT INTERNAL JUGULAR ECMO CANNULA (31 FR SPECTRUM) BEGAN TO ENTRAIN AIR INTO THE ECMO CIRCUIT. A FRACTURE IN ECMO CANNULA WAS NOTED AND THE PATIENT WAS TAKEN IMMEDIATELY TO THE OR (OPERATING ROOM) FOR CANNULA REVISION. NO ACTUAL ADVERSE OUTCOMES IDENTIFIED FOR THE PATIENT RELATED TO THIS ISSUE. MANUFACTURER RESPONSE FOR DUAL LUMEN 31 FR RA TO PA ECMO CANNULA, SPECTRUM (PER SITE REPORTER): ¿CEO FROM SPECTRUM MEDICAL STATED THAT THEY ARE AWARE OF THIS TYPE OF DELAMINATION HAPPENING ONCE BEFORE (I.E., THE DRAINAGE LUMEN COMING DETACHED FROM THE CONNECTOR HUB). THEIR INTERNAL INVESTIGATIONS SUGGESTED THAT DETACHMENT IS POSSIBLE WHEN ALCOHOL COMES INTO CONTACT WITH GLUE." SPECTRUM HAS INTRODUCED A GENERATION 2 CANNULA, WITH HEAT SHRINKING FEP (FLUORINATED ETHYLENE PROPYLENE) MATERIAL THAT IS SHRUNK OVER THE GLUE JOINT THAT ¿REDUCES THE POSSIBILITY OF ALCOHOL COMING INTO CONTACT WITH THE GLUE¿. SPECTRUM TO SHIP REPLACEMENTS TO HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2030448 DUAL LUMEN 31 FR RA TO PA ECMO CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF SPECTRUM MEDICAL INC

    Patients

    Seq Age Sex Outcome Treatment
    1 18980 DA Male