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[IPm] Smith's Medical voluntary recall



The nice folks at Smith's/Deltec asked that I pass this info on to 
everyone at Insulin Pumpers.

Their press release begins:

St. Paul, Minnesota, November 21, 2008 -- Smiths Medical MD, Inc. has 
issued a voluntary recall notification to customers for the Deltec 
Model 1800 Insulin Pump. Additional information regarding this action 
is available on the CozMore website at http://www.coxmore.com/letter/

the text of the letter follows:

################################

URGENT MEDICAL DEVICE RECALL  
Affected Devices: All Model 1800 Deltec Cozmo. Insulin Pumps. 

Date: November 20, 2008

Attention: Distributors, Clinicians, Patients and other Customers 

Description of the Problem:

Smiths Medical has become aware of a display irregularity with the 
Deltec Cozmo. Insulin Pump, Model 1800 ("Pump"). There have been a 
few customer events reported to Smiths Medical in which users 
reported that the amount of Extended Bolus reported as delivered was 
not accurately displayed by the Pump. The amount of Extended Bolus 
displayed as having been delivered, on the Pump4s Home Screen 2 and 
in the Bolus Summary Report, is less than what was programmed by the 
user. In these events, the Pumps delivered the correct amount of 
insulin as programmed by the user.

A lower than actually delivered amount of insulin will be displayed 
for an Extended Bolus on the Home Screen 2 and in the Bolus Summary 
Report only when all of the following conditions are met:

A Standard Bolus, including a Meal Bolus, Correction Bolus, or Custom 
Bolus, is started and completed or canceled while, An Extended or 
Combination Bolus is in progress and, The Extended or Combination 
Bolus delivers more than 2.55 units of insulin and, The Extended or 
Combination Bolus is allowed to run to completion as programmed.  

All other displays in the Pump, including the Delivery Summary and 
Complete History Report, correctly display the bolus amounts actually 
delivered. The CoZmanager. 2.0 software also provides the correct 
bolus amounts actually delivered. 

The Home Screen 2 and the Bolus Summary Report are the only displays 
that are affected. These screens do not affect delivery of insulin. 
The Pump will deliver the correct amount of insulin as programmed by 
the user. At no time is delivery accuracy affected.  

If the user programs an additional Bolus based solely on the extended 
Bolus delivered amount displayed on the Bolus Summary Report or Home 
Screen 2, there is a low potential risk of hypoglycemia.

This display irregularity has been corrected in the latest version of 
software, which is installed in all new and recertified Pumps built 
or distributed from Smiths Medical after November 9, 2008.

Advice on Action to be Taken by the User:

If you do not use the Extended or Combination Bolus features of the 
Pump, you can continue to use your Pump as usual.

If you do use the Extended or Combination Bolus features of the Pump, 
you can avoid the occurrence of the display irregularity by not 
starting or stopping a Standard Bolus, including a Meal Bolus, 
Correction Bolus or Custom Bolus, while an Extended or Combination 
Bolus is in progress. If you choose to start or stop a Standard 
Bolus, including a Meal Bolus, Correction Bolus or Custom Bolus, 
while an Extended or Combination Bolus is in progress, use the 
Complete History or Delivery Summary screen displays for confirmation 
of delivery information.  

If you are not comfortable with continuing to use your Pump, you can 
choose to have your Pump replaced with a recertified Pump with 
corrected software. Please select the replacement Pump option on the 
attached Confirmation Form. A Smiths Medical representative will 
contact you with shipping details for the replacement Pump and return 
of your current Pump - do not return your current Pump until you are 
contacted. Please complete and return the Confirmation Form (see 
Attachment 1) by using the enclosed return envelope; faxing the form 
to 1-800-628-6322; completing the form via the internet at 
http://www.cozmore.com/notice; or calling 1-800-501-5748, (USA only) 
to talk to a customer service representative.  

Please retain a copy of this Notice for future reference and as a 
reminder of this issue.
For additional information, please contact Smiths Medical MD, Inc. 
at:

Smiths Medical MD, Inc.
St. Paul, MN 55112 USA
Telephone: 1-800-501-5748, (USA only)
Fax: 1-800-628-6322


Hours of Call Center Operation:
Monday through Thursday: 7 a.m. through 7 p.m. Central Time
Friday: 7 a.m. through 5 p.m. Central Time
Saturdays and Sundays: Closed
Closed for Holidays: November 27-28, 2008, December 24-25, 2008, 
January 1, 2009

Smiths Medical has informed the U.S. Food and Drug Administration 
(FDA) of this situation. 

Smiths Medical is committed to providing quality products and service 
to its customers. We apologize for any inconvenience this situation 
may have caused. 


Smiths Medical MD, Inc.
Michael Herbert
Manager, Quality Systems

..
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