# MRHA Safety Notice (medtronic)



## ch1ps (Aug 28, 2013)

http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON309611?tabName=Device

I have contacted my DSN.  Should I be worried?  My infusion sets are on the list, but reservoirs are not.

Thanks


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## Riri (Aug 29, 2013)

I'm the same as you chips. All my infusion sets are out of one of the batches listed. Thing is I've been using them for the past 2 months. My reservoirs are all ok. I will phone Medtrnonic when they open at 8.30am.


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## everydayupsanddowns (Aug 29, 2013)

Still awaiting clarification on this...

First I heard was an announcement in June, so I don't know why they have re-dated it again (the lot numbers seem to be the same as the June notices).

As far as I can make out the *recall* only affects a limited number of reservoirs (none of the ones I have had recently have lot numbers that far back, but worth checking your stocks). Seems there were some batches that had increased chance of leaking/seal failure.

The other note seems to relate to all infusion sets, but only very obliquely. It is connected to the way you connect the reservoir to the set I think. There were new instructinos about which way up to hold things to make sure that the top of the reservoir didn't get covered in insulin (or other liquid). I'm not actually sure how that would be possible... but it must have happened to someone or other!

So it seems that there's nothing wrong with the sets as such, but just that you need to keep an eye on the top of the reservoir/inside of the tube connection when you are plugging everything together.

If you are on a Medtronic pump you should have had a note in the post about what to look for/avoid when connecting things up.

Does anyone else know anything different????


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## Riri (Aug 29, 2013)

Phoned Medtrnoic and it's exactly as the last poster described. Check the blue connector on the sets when filling the reservoir to see that they're not wet but they are not being recalled - just the batches of reservoirs listed. 
I told my DSN about the note this morning and she printed them off but then came back to me rather annoyed saying it was the same lots as before. I did tell her that I wasn't aware of this (but it seems that they are).  I also told her that when I asked the Medtronic customer service person earlier today whether he was aware of yesterday's notice, he said 'yes' so it has been re-issed for some reason. 
Confusion regins!


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## ch1ps (Aug 29, 2013)

Called Medtronic same as replies above.  Said check reservoir before connecting to make sure it's dry after filling.  No recall scheduled - yet.


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