Monday, November 14, 2011

Update #2 on our MicroCLAVE issue...

I just wanted to update with information that was sent to me today from ICU Medical. Below is the string of emails from today:

From: Jason OConnor
Sent: Sunday, November 13, 2011 9:15 PM
To: Alison Burcar
Subject: Re: MicroCLAVE

Hi Alison:

Thanks for the quick response.You were very close with the suggestion about the fractures. In our case it appears to actually be slight irregularities in the very tip of Vygon extension tubing that is causing the issue.

It lookes like these small irregularities are causing the extension set to not seal properly with the split septum in the MicroCLAVE, which is then leaking fluid into the side of the clave and then out the side.

I have described all of what we learned today on our end on Sam's blog, can you please take a look at it to verify that what we are seeing makes sense and that we have given a fair despcription of the probelm we are experiencing?

Thanks,
Jason


From: Alison Burcar
To: Jason OConnor
Sent: Monday, November 14, 2011 12:00 PM
Subject: RE: MicroCLAVE

Wow!

One might expect that there is some sort of engineering experience in the family, but then again it could just be that you are a parent like the rest of us doing the very best you can for your son.

You are right about everything in the post – and our experience also confirms issues with the Vygon product. The dynamic seal requirement on the head of the MicroCLAVE septum, is both a blessing and a curse. While the research shows that it is this feature that best inhibits bacterial transfer into the fluid path, it can also be problematic if the mating device has deficiencies. I would however, urge you to reconsider the positive pressure route, because these inherent designs that you have described so well on the blog have also been implicated as a risk factor for bloodstream infections. In fact the FDA issued a warning for these devices in 2010 and ordered all manufacturers to conduct post market surveillance studies related to the their safety (including our own CLC2000). I have attached the warning letter.

ICU Medical has actually undergone some significant design changes to help with the subject because ‘real life’ dictates our business, and our connectors are constantly subjected to outside influences which we cannot just sit back and point fingers at. For this reason, we have elected to now include a seal between the housing and the luer of the MicroCLAVE to prevent this type of leak event. I am sure that you recognize that there could be some very small amount of fluid loss inside the housing if the Vygon set were still to be used, but that type of volume is probably not a concern. This change will be in effect come January 1, 2012. We are also prototyping a slightly softer silicone that may help accommodate irregularities like in the Vygon product, but that change would have widespread design implications, so at this time I cannot make specific commitments about when that could be available.

As a manufacturer, our approach is to solve the problem and in this case we would hope that Vygon would take action, but these types of improvements do cost companies so unfortunately that is not always the case. These irregularities are a molding/manufacturing defect, and they are controllable. If you are willing to provide the part number of the Vygon product so I can match it up, I would be happy to send you a few cases of replacement tubing that we make, at no charge. I would also replace your MicroCLAVEs that were consumed through your investigation, if elect to continue with our product.Please let me know.

Alison Burcar
Vice President, Product Development

From: Jason OConnor
Sent: Monday, November 14, 2011 12:09 PM
To: Alison Burcar
Subject: Re: MicroCLAVE

Alison:

I have read the FDA warning previously, and I beleive this is one of the resons that our homecare company stopped carrying our previous brand and went to the MicroCLAVE (I beleive there was a cost factor involved as well).

As I have stated previously, we love the small size and low profile of the MicroCLAVE. As we are working through solutions with out provider we had to weigh the risk of using the positive placement device vs. the risk of running into a major leak like we did - and I beleive that I would weigh on the side of the leak free connection. However, with the information that you have provided me in your most recent message we will most likely stick with the MicroCLAVE.

I appretiate that your company is taking steps to modify the design of your product the help reduce the chances of something like this occurring. I have contacted Vygon as well regarding the flaws that I see in their product, but I highly doubt that they will be as responsive as you have been to our inquiry.

The set we are using is Ref 1155.80 Lectro-Spiral 1X2 mm - L300 cm - Vol 2.8ml. We were not aware that any other company was making this type of set, and I don't remember if I ever stated anywhere that this was a coiled set that we are using. If you make a coiled set like this it will be the best news I have heard in a long time. Otherwise we would be more than willing to try out a non coiled extension set to see how it goes, especially if we find it too be leak free.

I think we only used 2 or 3 claves when we were investigating, but we won't say no if you want to throw a couple our way.Thanks again for all of your help on this! We truly appreciate the response we have received.

Jason



From: Alison Burcar
To: Jason OConnor
Sent: Monday, November 14, 2011 5:00 PM
Subject: RE: MicroCLAVE

You did actually mention spiral in your email, which causes me to stick my foot in my mouth a bit. We make the product in our Slovakia facility for EU distribution, so there is a little bit of legwork to bring into the states. But on that same note, I agree that there have been numerous requests and I can try to light a fire under it. I don’t want to recommend an uncoiled set – I have a 2 ½ year old and I hope Sam gets to act like him at least 1/10th of the time.

What I could still offer you immediately is an adapter, an anti-siphon valve to be exact, that can go at the end of your current Vygon set and then connect directly (without leaking!) to your MicroCLAVE. I’ll send you case regardless, just so you can check it out. And when I hear more specifics on when I can get a coiled set here in the states I will let you, and our distribution network here in the US know about it.

And a sincere thank you for taking the time to explain your situation in-depth. As I mentioned, we were aware of this type of leak event, but it had only occurred in a Hospital setting where any type of fluid loss can be immediately remedied because for the most part, clinicians are readily on hand to notice something like that. It paints a whole other picture for concerns with the home care patient. And while I feel we are on the right track with implementation of the seal, it helps me better understand from a broad picture our design risks and how our devices need to continually evolve. I couldn’t do that if I didn’t hear from users like you. We don’t really expect that commodity sets like the Vygon one will actually improve in the US, we actually think they are in demise as manufacturers are looking to low cost, foreign suppliers. Much of my job is to ensure that our devices can still work effectively, even when faced with irregular or deficient connections. Best of luck to you and Sam. Please let me know if I can help further.

Alison Burcar
Vice President, Product Development

On Sunday I also sent a message to Vygon, the company that manufactures the coiled extension sets that we use. So far no response from them.

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