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[IP] Recall of Disetronic Infusion Pump - ALL MODELS April 2003
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
Regulatory Affairs Specialist and pumpmom to 19 m.o. Sigrid
(in reference to:)
"Denise Owens" <email @ redacted> wrote:
Cutting the relevent info from the above URL. The only entry about
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
Disetronic D-TRON Insulin Infusion Pump, Models 8100001 D-TRON (blue)
8100005 D-TRON (anthracite). Recall # Z-1350-02. This correction was
previously classified as a Class II. The health risk was reevaluated
receipt of new information.
All Serial numbers.
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.
Some pumps started programming a bolus that was not initiated by the
user, and the delivery of an unintended bolus was made unless
the device user.
VOLUME OF PRODUCT IN COMMERCE
3357 insulin infusion pumps.
Denise wrote (in regards to a Disetronic pump recall):
When a Quality Assurance guy gave me this information this morning and
dated April 2003, I became alarmed and sent it out to the group. They
use the Deltec Cozmo. I'm not familiar with Disetronic line of pumps.
you were able to decipher this information and that it is not 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.
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