A Class I recall has been issued for Synbiq one and two-channel infusion systems, because there is a chance that they could release an unrestricted flow of drugs into a patient’s body.
The Symbiq infuser recall was announced in March and given Class I status by FDA this week. A Class I recall is the most serious category of medical device recall, indicating that the FDA has determined that use of the defective device is likely to cause serious injury or death.
The classification came after Hospira sent additional information about the Symbiq infuser recall in a letter to customers (pdf) on September 13. If the medication cassette is not replaced in a specific manner, the infuser may release an unrestricted amount of drugs into the patient’s system without activating the device’s “Check Flow Stop” alarm, which is meant to prevent such an incident. This could lead to a drug overdose and could be fatal or cause severe injuries, particularly if the patient is already critically ill.
Infusion sets are designed to help health care professionals deliver specifically measured amounts drugs, blood products, and other solutions intravenously into patients.
The recall affects several lots of Symbiq One-Channel Infusers, with model number 16026, and Symbiq two-channel infusers, with model numbers 16027. The specific lots affected by the Symbiq recall are available in the FDA recall announcement.
The same two models were recalled in July after Hospira sent out a clinical bulletin to customers saying that there have been multiple reports of the Symbiq infusers failing to detect air in the lines. There have been no injuries or illnesses reported in connection to the defective infusers, but Hospira said it sent the letter after it received a report that one patient had received an unrestricted flow of drugs after it announced the recall in March. The letter does not indicate whether the patient was injured.
The FDA launched a new infusion pump safety initiative in April. The new initiative requires manufacturers to undergo more risk assessments before gaining approval for new or modified devices, and they will be expected to submit additional design and engineering information for premarket approval.
The new guidance comes following an FDA advisory panel meeting in March, which was called by regulatory agency due to a disturbing trend in the quality of infusion pumps. According to FDA, there have been 56,000 adverse event reports from people reporting problems with infusion pumps in the last five years. In addition, there were 87 infusion pump recalls announced between 2005 and 2009.