Ellen
11-21-2008, 04:28 PM
Letter (http://www.cozmore.com/letter/)
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 Pump’s 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
Enclosures: Attachment 1: Confirmation Form
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 Pump’s 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
Enclosures: Attachment 1: Confirmation Form