The Food and Drug Administration has sent out a notification that the I-Flow ON-Q Pump with ONDEMAND Bolus Button may not lock in the down position when depressed, and the orange bolus refill indicator may stay in the lowest position.
In such instances, patients may receive continuous infusion at a rate greater than expected and may suffer serious health consequences, including death, as a result.
The On-Q pump with ONDEMAND bolus button is used for continuous and intermittent delivery of medicines to or around surgical wound sites and nearby nerves for pre-, peri- and postoperative regional anesthetic and pain management.
The firm already had sent a voluntary recall notice to customers. The FDA said customers should identify and quarantine all affected products in their inventories.
The recall notice, with a list of affected product numbers, is available at www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm317826.htm.
In such instances, patients may receive continuous infusion at a rate greater than expected and may suffer serious health consequences, including death, as a result.
The On-Q pump with ONDEMAND bolus button is used for continuous and intermittent delivery of medicines to or around surgical wound sites and nearby nerves for pre-, peri- and postoperative regional anesthetic and pain management.
The firm already had sent a voluntary recall notice to customers. The FDA said customers should identify and quarantine all affected products in their inventories.
The recall notice, with a list of affected product numbers, is available at www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm317826.htm.
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