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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter 6060E Epidural Pump

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  Class 2 Device Recall Baxter 6060E Epidural Pump see related information
Date Initiated by Firm June 13, 2005
Date Posted August 06, 2005
Recall Status1 Terminated 3 on June 19, 2007
Recall Number Z-1089-05
Recall Event ID 32254
Product Classification Pump, Infusion - Product Code FRN
Product Baxter 6060E Epidural Infusion Pump, product code 2L9351 and 606000-40EL; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore
Code Information All serial numbers
Recalling Firm/
Manufacturer
Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake IL 60073
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall
There is an overinfusion condition in the Intermittent mode where the pump may continue to deliver at the higher dose rate instead of switching to the lower keep open rate once the first dose is completed.
FDA Determined
Cause 2
Other
Action Baxter sent the 6/13/05 Urgent Device Correction letter to all Baxter 6060 and 6060E Infusion Pump customers to inform them of a software anomaly which allows the pump to overinfuse in the Intermittent mode of the 6060 pump if the following specific sequence of events occur: * the infusion is running in intermittent mode; * the pump is delivering at the Keep Open (KO) rate; * the pump is then powered off and on; * the clinician initiates new programming of the pump by selecting NO at the 'Resume KO Dose 1?' prompt and selecting YES at the 'Yes to Program' prompt; * the clinician powers the pump off and on again; * and the clinician selects YES at the 'Resume KO Dose 1?' prompt. Until the software upgrade is available, Baxter recommended that the accounts notify healthcare providers of the potential for an overinfusion condition in Intermittent mode if the above sequence is performed during an infusion, and to utilize the Lockout mode after programming the pump. Any questions were directed to Baxter''s Medication Delivery Services at 1-800-843-7867. The letter also informed the accounts of two patient deaths due to medication delivery errors resulting from improper programming of the infusion parameters into the 6060 and 6060E pumps, and reports where the infusion parameters were modified by untrained individuals, which may result in overinfusion or underinfusion conditions. The letter stressed that programming of the pump must be performed only by trained clinicians, or healthcare providers trained and deemed competent by trained clinicians or under the direct supervision of trained clinicians; the Lockout mode feature of the pump should be used to prevent unauthorized changes to the pump programming; and the pump security codes, which disable the Lockout mode, must not be released to anyone other than trained healthcare professionals. A copy of the warning from the Operator''s Manual was included with the letter. Any questions were referred to the Center fo
Distribution Nationwide and internationally to Belgium, Germany, Finland, France, the United Kingdom, Ireland, Sweden, Norway, Canada, Japan, New Zealand and Australia.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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