The Health Canada posted a medical device safety alert concerning On-Q Pump C-Cloc with Ondemand Bolus button (Model number CB003 and CB006), manufactured by I-Flow Corporation.
The manufacturer recently determined that in a small quantity of On-Q Pumps including the Ondemand Bolus Button, the valve that activates flow of local anesthetic from bolus reservoir to the patient is defective. In this condition, patients may receive continuous infusion of local anesthetic to the tissue space at a rate greater than desired (i.e. Main basal rate + bolus reservoir fill rate).
For details, please refer to Health Canada website
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_apr-june_2012-eng.php.
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 15 June 2012