On August 31, 2012, the U.S. Food & Drug Administration (FDA) issued a press release notifying healthcare professionals that the I-Flow ON-Q Pump with ONDEMAND Bolus Button is being recalled on a nationwide level. This recall is being issued in response to numerous reports of the device failing to lock down when depressed, and/or the orange bolus indicator staying in the lowest most position. When this occurs, the patient may receive continuous infusion of medication at a greater rate than expected, which can result in adverse health complications and even death.
What’s the Problem?
The On-Q pump with ONDEMAND bolus button is designed to provide continuous and intermittent delivery of local anesthetics and narcotics to or around surgical wound sites. The devices are typically used for regional anesthetic and pain management before, during and after the following surgical procedures:
- ACL knee surgery
- Cesarean section
- Gastric Bypass
- Breast Augmentation
- Arthroscopic shoulder surgery
On May 8, 2012, I-Flow Corporation sent a voluntary recall notice to its customers who purchased the ON-Q pump with ONDEMAND bolus button describing the problem with the device. The company advised customers to identify all affected products within their inventory and quarantine said products. This is a Class I recall, which is the most serious type of recall allowed by law that involves situations in which there is a reasonable probability that use of the product in question will cause adverse health complications or death.