August 31, 2012
I-Flow ON-Q Pump with ONDEMAND Bolus Button: Class I Recall - Risk of Continuous Infusion at a Rate Greater Than Expected
AUDIENCE: Risk Manager, Nursing
ISSUE: FDA notified healthcare professionals that the I-Flow ON-Q Pump with ONDEMAND Bolus Button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowest most position. When this occurs, the patient may receive continuous infusion at a rate greater than expected. As a result, this product may cause serious adverse health consequences, including death. See the Recall Notice for a listing of affected product numbers.
BACKGROUND: The On-Q pump with ONDEMAND bolus button is used for continuous and intermittent delivery of medicines (such as local anesthetics or narcotics) to or around surgical wound sites and/or to nearby nerves for pre-operative, during the procedure/surgery (perioperative), and for post-operative regional anesthetic and pain management.
RECOMMENDATION: On May 8, 2012, the firm sent an IMPORTANT VOLUNTARY RECALL NOTICE to its customers who purchased the ON-Q pump with ONDEMAND bolus button. Customers should identify all affected products within your inventory and Quarantine the affected products.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[08/31/2012 - Recall Notice - FDA]