Description of Event or Problem · 0
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN MC3 CRESCENT JUGULAR DUAL LUMEN CATHETER, IT WAS REPORTED THAT WHEN THE CUSTOMER CONNECTED THE EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) CIRCUIT TUBING, THERE WAS WHAT LOOKED TO BE A TEAR IN THE CANNULA, NEAR THE CONNECTOR. THE CUSTOMER CHANGED TO A NEW CRESCENT, BUT DURING THE EXCHANGE THE TEAR WORSENED AND EVENTUALLY BROKE OFF OUTSIDE THE PATIENT. THE PATIENT EXPERIENCED HEMORRHAGIC SHOCK DUE TO HAVING TO EXCHANGE THE CANNULA. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PROCEDURE HAD BEEN A RELATIVELY SMOOTH CANNULATION UP UNTIL THAT POINT. THE CUSTOMER'S CLAMPS WERE NEVER ON THE AFFECTED PORTION OF THE CANNULA, AND WHILE IT SEEMS THAT IT WOULD HAVE MOST LIKELY TORN DURING CONNECTION OF THE TUBING TO THE CANNULA, THE CONNECTION WAS VERY SMOOTH, AND THE PHYSICIAN DID NOT STRUGGLE TO GET IT ON OR HAVE TO DISCONNECT AND RECONNECT. THEY ONLY DISCOVERED THE TEAR AFTER UNCLAMPING THE CIRCUIT AND SUDDENLY HAVING BLOOD LEAKING. WHILE CHANGING OUT THE CANNULA, IT CONTINUED TO TEAR, SO RECANNULATING THE NEW CRESCENT WAS DELAYED. ULTIMATELY THE PATIENT WENT INTO HEMORRHAGIC SHOCK AND NEEDED BLOOD BUT SURVIVED ECMO AND WAS DECANNULATED.