Company:Smiths Medical MD, Inc
Date of Enforcement Report 4/22/2009
Class:ll
PRODUCT
a) Deltec Cozmo Insulin Pump, Model 1800. Deltec Cozmo Insulin Pumps are ambulatory electromechanical pumps used for delivering insulin to patients with diabetes. The pump is used mainly by homecare patients but, can also be used in a healthcare facility, Recall # Z-0988-2009;
b) Deltec Cozmo Insulin Pump, Model 1700 containing 1800 software. Deltec Cozmo Insulin Pumps are ambulatory electromechanical pumps used for delivering insulin to patients with diabetes. The pump is used mainly by homecare patients, but can also be used in a healthcare facility, Recall # Z-0989-2009
REASON
There have been adverse events reported that the amount of Extended Bolus delivered was not accurately displayed by the Pump. The amount of extended Bolus displayed on the Pump 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. 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 risk of hypoglycemia.
RECALLING FIRM/MANUFACTURER
Smiths Medical MD, Inc., Saint Paul , MN , by letter dated November 20, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
17,047 units
DISTRIBUTION
Nationwide and Internationally
