All GOPump Rapid Recovery System kits and GOBlock Kits manufactured with flow control components assembled prior to July 2012 are the subject of a nationwide recall. These products have been found to potentially cause excessively high flow rates, which presents a risk of patient toxicity and serious injury (e.g., seizure, dysrhythmia, or death) due to the rapid influx of medication particularly in patients with low body mass or advanced age. To date, there have been five complaints received, two of which involved serious consequences. Symbios Medical Products has identified the root cause and put in place processes to address the issue.
The Symbios GOPump is a postoperative infusion system that attaches to the patient’s catheter and automatically directs local anesthetic to the pain source, dulling the pain and reducing or eliminating the need for additional painkillers or narcotics. GOPump provides continuous infusion of a local anesthetic at a patient’s surgical site to relieve pain that patients experience following surgical procedures. It is designed for both in-patient and home use.
Products subject to this recall were distributed throughout the United States between April 1st, 2011, and April 30th, 2013. Distributors and clinical provider sites using these Symbios Medical Products have been notified of the affected product codes and lot numbers.
See the Recall
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication.