2011年3月30日星期三

Access Scientific POWERWAND Gets FDA Clearance

Access Scientific, from San Diego, has received FDA clearance for its POWERWAND power-injectable vascular access cannula. As we reported before, the WAND cannulas can be used for central venous access, integrating everything necessary for a modified Seldinger technique into one device. The POWERWAND is purposed for extended-dwell and allows for power-injection of fluids or medication, but also for blood withdrawal.
CE mark has also recently been obtained and initial distribution will start in Britain, Australia and South Africa. Preliminary results of the first clinical trial with the device will be presented at the Infusion Nurses Society annual meeting in May 2011.
Mrs Anderson said that she heard an unusual "clunk" sound when the trocar was inserted and that as soon as a camera was inserted a large amount of blood could be seen.

Dr Richard Harrison also gave evidence telling the court that when he arrived he saw that Mrs Clarke-Lewis was undergoing a massive blood transfusion.

"We removed the packing (gauze) but the source was hard to discover because of the massive amount of blood and within moments Heidi had a second cardiac arrest," Dr Harrison said.

"We repacked (the pelvic cavity) but she didn't respond to resuscitation attempts."

The solicitor for the Clarke and Lewis families suggested that careless insertion of the trocar could lead to "catastrophic damage" and surgeon's should have recognised the issue earlier.

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