GOPump and GOBlock Pain Pump Kit Recall Issued After Serious injuries

An FDA safety advisory has been issued about a risk of problems with Symbios GoPump and GOBlock kits, which were recalled after many of the pain pumps were found to cause excessively high flow rates in some systems.

A GoPump and GoBlock pain pump recall was issued on May 10, after at least five complaints were received, including several that involved serious adverse effects. The manufacturer has indicated that they now understand the cause of the problems and have begun to correct the issue.

Surgical pain pumps are used to patients following larger incision surgeries. The pumps are made to run for several days following surgery to deliver local anesthesia to the area in pain. They also are used to block pain to specific parts of the body by delivering anesthesia directly to the site.

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The devices are designed to offer patients pain relief without relying on narcotic pain medications. It delivers anesthesia while providing patients with an opportunity to be more mobile and complete normal daily activities sooner.

High flow rates in a surgical pain pump can put a patient at higher risk for toxicity and other serious injuries, such as seizure, dysrhythmia and even death as a result of the rapid influx of medication. Rapid delivery of the anesthesia poses a greater risk to patients with low body mass and the elderly, who may be affected by the medication more easily.

The surgical pain pumps are manufactured by Symbios Medical Products in Indianapolis, Indiana. The recalled products were manufactured prior to July 2012 and distributed between April 1, 2012, and April 30, 2013. The GOPump and GOBlock kits were manufactured with flow control components which seem to be faulty.

This is the second GOPump recall this year. In March, the FDA declared a class I recall for GOPump Elastromeric Infusion Pump kits for flow problems as well.

Symbios has notified it’s distributors and clinical providers of the affected product codes and lot numbers involved in the national recall. The company states they began recall action immediately following receipt of information concerning product safety and operation problems.

For more information concerning the recall contact Symbios 317-225-4447 ext 25 or visit www.symbiosmedical.com.

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