Pharmacy Services

I-FLOW ON-Q Pump with ONDEMAND Bolus Button

September 6, 2012

FDA is informing healthcare providers of a recall of the I-Flow ON-Q Pump with an ONDEMAND Bolus Button. When the button is depressed, it may not lock when in the down position. This malfunction may create a continuous infusion of bolus medications.

The ON-Q system with an ONDEMAND Button is designed to be used for either continuous or bolus infusions of medications. It is commonly used for local anesthetics or narcotics in patients needing anesthetic or pain management surrounding surgical procedures or surgical wounds. Bolus buttons of affected units may not remain in the down position when it is depressed, or the bolus refill indicator may remain in the lowest position, creating a continuous infusion instead of a bolus dose. Because of the medications typically used in this system, this mechanical failure creates a potential for severe adverse events, including death.

Affected devices were manufactured from October 2002 through April 2012 and distributed between May 2010 through May 2012. A list of all affected devices with model numbers and part numbers can be found at the following link:

Discontinue use and quarantine any affected devices. Call 1-920-969-4565 for instructions on device return and credits. Call I-Flow customer service at 1-800-448-3569 or I-Flow 24-hour technical support at 1-800-444-2728 with any questions pertaining to this recall. Report any adverse events from the use of this product to FDA’s MedWatch Safety and Adverse Event Reporting Program.

Additional information is available at the following links:

Updated
September 6, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.