Patient information were not provided.Sorin group italia manufactures venous pediatric cannula.The incident occurred in (b)(6).At the submission of the case, the customer has provided a picture of the cracked cannula.The involved device has been requested for return to sorin group italia for investigation.Through follow up with the customer livanova learned that cannulae cracked before being suture.After venous cannulae has been put in superior vena cava, surgeon continued to setup venous cannulae for inferior vena cava, the team saw that venous pressure had been dropped and found out cannulae cracked, surgeon changed another cannulae and continued the case.Surgeon also claim to me that he had problem with silicone tube of cannulae before, the tube had been broken when connect with tubing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Not yet received.
|