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.

Sunday, November 13, 2011

An update on our clave issue...

I just want to say that I think determining the cause of our issue on a Sunday isn't something that I really thought possible. We now know almost certainly what the issue is, and technically it isn't the clave. The MicroCLAVE is functioning properly and I do not think there is necessarily a problem with the device.

To begin with, I sent an email to ICU Medical this morning. I stated the issue I was having and asked them to read the blog post from earlier today. I received a response this afternoon:

Jason,

I am very concerned that you have had this experience with our product in your home. Your detailed information and video is quite helpful, as this type of event has occurred recently in other areas and I feel very confident that I do know the cause. The 'smoking gun' in your account is how you describe that when you disconnected everything, it all looked perfect. Followed with how you attempted to try six other MicroCLAVEs in sequence, all with the same result.

As I am unfortunately not in the office today, I will send you some internal investigations that we have conducted which duplicated this problem first thing tomorrow. As an immediate measure, if you change-out your TPN delivery set (the one that connects into the MicroCLAVE), and only tighten until a friction fit is felt, I believe the leaking will stop. The problem is most likely hairline fractures in the luer of the tubing set that are almost invisible to the naked eye. These fractures allow for fluid to escape within the MicroCLAVE housing and out the area that is clearly visible in your video.

I am truly sorry for your experience, and will have more information for you tomorrow.

Alison Burcar
Vice President of Product Development


So, the advice that was given regarding the hairline fractures wasn't quite it, but it did lead me to determining why we were experiencing the leaking, and only with the MicroCLAVES and not the other claves we were using. In order to explain, you have to know a little more about these devices.

The devices that we have not had any trouble with have all been positive displacement devices. (Posiflow, MaxPlus, Ultrasite, etc... are examples) The inside of these devices looks similar to this:

When a syringe or extension set is inserted into the clave, it pushes the plunger out of the way. The inner chamber fills with fluid and then moved into the line through the connection in the bottom.

The MicroCLAVE ( and other devices like it) uses a straight fluid path. There are several benefits to this delivery system compared to the first. The straight fluid path is, however, why we are experiencing a problem with just the MicroCLAVES and not the other devices we were using. In the straight fluid path the tip of the syringe or extension set, when inserted into the clave, pushes the septum (plunger) down and open. A seal is formed between the split septum and the syringe or extension set.

Where the problem lies is that if there is any irregularity in the tip of the syringe or extension set it can't seal properly with the split septum which can cause fluid to flow through the area of the clave that is outside of the fluid path (Indicated in red).

We use an extra extension on Sam's IV to give him more length. (Vygon Lectro Spiral). These are made out of a slightly softer material than a typical extension set or syringe. After opening several packages today it appears that there is frequently small irregularities in the tip of the extension sets which is what is causing the leaks. These flaws are so minor that I wouldn't have noticed them if I wasn't looking closely. I don't feel that this is a defect, but is most definitely the cause of our issues.

So it appears that really these two products should not be used together. Hopefully now we can convince our homecare company to go back to a positive displacement device or provide a shorter extension with less irregularity that we can use in between the Vygon tubing and the MicroCLAVE.

Thank You to Alison Burcar from ICU Medical for getting back to me on a Sunday. Hopefully my research today will help someone else who may be having a similar problem.

For our Medical Friends - If you use ICU Medical Microclaves

For those of you who do not use TPN, this post probably won't make much sense to you. For our TPN friends however, this is a post you will want to read, especially if you use ICU Medical , Inc. MicroCLAVES. Here is what the package/product looks like:



About three months ago after I had put Sam to bed I went to check on him. I found him laying in a puddle of TPN and Omegaven. Panic set in as we accessed what was going on. After checking that all of his connections were secure I moved on to looking at his line hoping that we weren't going to find a bad line or a cracked hub. Everything looked perfect. We began running his PN again and to my horror I watched as fluid began to leak out of a seam in his clave.

We changed out the clave and hooked him back up and the new clave began to leak again. We went through six claves before we found one that didn't leak. The next day we sent all of the ones that had leaked back to our homecare company, they sent us replacement claves from a different lot.

About a week later one of the new claves began leaking from the same seam. Luckily I had received a box of supplies from a former TPN patient that had a different brand and style of clave and I switched out to one of those. Up until this week I have been able to secure a supply of other brands of claves.

On Friday I talked to our homecare company. I had received another different lot number if MicroCLAVES and we were going to begin using them again. Friday night there were no issues.

On Saturday we were visiting family about 45 miles from home. We hooked up Sam's TPN, put him in his car seat and drove home. When I went to pick him up and I put my hand behind him I was met with a very wet surprise. Not the first time I have been met with a wet surprise when picking Sam up, but when I pulled my hand out I could feel that it was sticky and I knew right away that he was leaking TPN from somewhere.

As we to began to undress him I found that blood had backed up into his line. There was a mix of TPN, blood, and Omegaven leaking from his clave. And he was drenched.



Luckily I had kept one spare clave of another brand just in case so we were able to get him cleaned up and get his TPN running again.

If you understand what most of this post said you are probably reading this in absolute horror. For the rest of you I will explain the concern. Sam's central line is a plastic tube that routes directly into a vein near his heart. Introducing any contaminant into this line can be deadly to him. Having clave leak the way it did opened him up to a huge infection risk. The line is meant to be a closed system. If, instead of blood backing up into the line, air had leaked in through the clave it could have potentially caused and air embolism. This could have killed him.

There is a definite problem with this product. I will be waiting to see what else our homecare company can get for us because I will never use this product ever again, even if it is redesigned. Just to show that we are not crazy, here is a video of the actual clave leaking as I flush it with saline:


video

Please feel free to share this info with others who might find it useful. For this type of product to fail in the way it has is completely unacceptable.

***UPDATE**** I wanted to say that in no way am I stating that this company has acted in any negligent manner. When issues like this arise, it is only fair to give the manufacturer a chance to respond and rectify a problem. I have now heard from two other people who have had similar problems with this device, but neither leaked quite as bad as the video I have posted here.

I have contacted the manufacturer directly via email and will update here on what type of response I receive from them.

***UPDATE 2**** If you are coming directly to this post, please make sure you also read the more recent post that has information regarding why we are having this problem.

Saturday, November 12, 2011

As good as it gets

Getting a good picture of Sam can be a challenge.  Getting a good picture and a smile at the same time has just about proved impossible.  So we'll take this years school picture...

I am not sure when he grew up so much, but there really isn't any trace of baby left in Sam.  He has progressed to being a little boy, something we were never sure we would get to see.

Nothing much else new to report.  Sam and I will be headed to Boston in the coming week.  We are still dealing with granulation tissue at his central line site, and we most likely will have to deal with it until there is a need to change the line and place a new one.

His vomiting fits have almost completely vanished since we introduced an oral probiotic to his daily medications.  It's more of a guessing game really, as we could just be in one of his good periods, but we will take in either way.

Sam is doing well in school and making great strides in his speech development.  We are still hoping that he will be doing well enough at the end of 4K next school year to join his brother in the Spanish bilingual program at school.  If he is not far enough along developmentally, then he will need to attend school in a regular classroom, at a different school than his brother, which will break Ryan's heart.  Ryan is already excited to be riding the bus with Sam to school a year and a half in advance.

Thanks to everyone who has made purchases at the Selling for Sam site.  Deb has been busy creating all kinds of new items for the store.  Don't forget she takes customer orders if you are looking for something you don't see there.