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Who this can affect: Those receiving Arrow Sheath Introducers
A hospital reported a deadly central venous air embolism caused by the separation of a certain manufacturer’s side port/hemostasis valve catheter-to-sheath adapter from the percutaneous sheath hub. This occurred after the standard Luer-lock fitting disconnected when a patient was moved from a bed to a chair. The FDA has received reports of other fatalities caused by air embolism and total blood loss involving the same manufacturer’s side port/hemostasis valve adapters from its introducer sheaths.
Arrow manufactures a percutaneous sheath introducer, which aids the insertion of catheters into a patient. A venous air embolism is a deadly complication that occurs during surgery where the operative site is 5 cm or more above the right atrium or if gas is forced under pressure into a body cavity. It can occur during brain surgery, head and neck surgery, cesarean sections and laparoscopic procedures.
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02-05-2009 @ 12:58 PM