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[IP] Recall of Disetronic Infusion Pump - ALL MODELS April 2003



  Hey Denise,

Don't feel bad; this was NOT a false alarm on your part.   I got the 
same email your Quality Assurance guy received today, and the way the 
email from the FDA read, you wouldn't have known it was an "old" recall 
without going through the website.    The reason it was "news" today 
from the FDA is that the recall was just upgraded from Class II to 
Class I (with Class I being more serious).  Now, why it was just now 
upgraded I don't know, and I can't find any explanation from the FDA.
Per the FDA website http://www.fda.gov/cdrh/recalls/recall-061702.html:
"Reason for Recall:	Some pumps started programming a bolus of insulin 
that was not initiated by the pump user and the delivery of an 
unintended bolus was made unless it was stopped by the device user.
FDA Comment:	FDA considers that the probability of life threatening 
consequences is possible by use of this model pump."
Well, DUH!  It's life-threatening today, but it wasn't yesterday?

I actually searched through the FDA website for recalls on all the pump 
manufacturers before we got my daughter's pump, and all of the 
manufacturers did have a history of recalls or other FDA enforcement 
actions for various things.  (Deltec at the time didn't have any 
recalls on the Cozmo, but they did have some on their other infusion 
pumps.)  Some recalls however were scarier than others, and I think 
this one scared me the most.  There is tons of information on the FDA 
website, and they really are trying to make it more user-friendly every 
day.....

Maria
Regulatory Affairs Specialist and pumpmom to 19 m.o. Sigrid

(in reference to:)
"Denise Owens" <email @ redacted> wrote:
> http://www.fda.gov/bbs/topics/enforce/2003/ENF00791.html

Cutting the relevent info from the above URL.  The only entry about
Disetronic is:

- -----
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
_________________________________
PRODUCT
Disetronic D-TRON Insulin Infusion Pump, Models 8100001 D-TRON (blue) 
and
8100005 D-TRON (anthracite). Recall # Z-1350-02. This correction was
previously classified as a Class II. The health risk was reevaluated 
after
receipt of new information.
CODE
All Serial numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Disetronic Medical Systems, Inc. St. Paul, MN, by letter
dated June 17, 2002.
Manufacturer: Disetronic Medical Systems AG Burgdorf, Switzerland. Firm
initiated recall is ongoing.
REASON
Some pumps started programming a bolus that was not initiated by the 
pump
user, and the delivery of an unintended bolus was made unless 
interrupted by
the device user.
VOLUME OF PRODUCT IN COMMERCE
3357 insulin infusion pumps.
DISTRIBUTION
Nationwide.

Denise wrote (in regards to a Disetronic pump recall):

When a Quality Assurance guy gave me this information this morning and 
it was
dated April 2003, I became alarmed and sent it out to the group. They 
know we
use the Deltec Cozmo. I'm not familiar with Disetronic line of pumps. 
I'm glad
you were able to decipher this information and that it is not as 
frightening as
I initially thought.

  To be honest, this is what scares me about our pump. This kills people,
especially when they are sleeping. I'm nervous now.


Denise
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