Sunday, November 13, 2011

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.

5 comments:

  1. Omg! I used this product for 5 weeks while we were in Omaha because we were so far from home! Wasn't impressed with them then. Glad we areback to our MP1000.

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  2. WOW! i am so, so sorry you experienced that!!! they were actually our favorite type of caps because they were bigger than most and easiest to change out (least likely to get contaminated in my opinion). could there be some sort of incompatibility between the TPN tubing and the caps?! how upsetting and scary. praying Sam stays well and you guys can find something that works!!! all the best, Jackie K.

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  3. That is terifying! My daughter is on TPN 22 hours a day and seeing that video made me gasp. We don't use those claves anymore thank goodness, we use Invision Plus claves.

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  4. Thank you so much for sharing this information. We contacted our home care company right away and this is a summary of what they said: They have known for a number of years that the Microclave and Vygon are a mismatch and they make sure no consumer is sent this combination. Their investigation centered on the Vygon's inability to activate the one-way valve in the Microclave. In most or all of their cases this resulted in an occlusion alarm rather than a leak. They contacted both manufacturers in the past but will do so again to pass on, again, their findings.

    We found this very timely because we always use an anti siphon valve with our cadd prism tubing and vygon. We found ourselves with different tubing recently and went crazy with the vygon to CLC2000 connection. It was difficult to get the cap off the vygon and once attached it looked like it wasn't going to stay attached. Have never used the microclave but we absolutely love the CLC2000 and know it plays a part in our ability to keep things sterile. Our son's line is 9 years old now! We love the "handle" on the clc2000 because we can use an alcohol prep pap to hold it, and stabilize the line/cap for maximum friction etc. all without ever contaminating anything with our skin!

    Once again, thank you so much for the information. The video was- oh so effective in showing the horror...

    Best wishes going forward!

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