- Smiths Medical’s recall of syringe infusion pumps has been categorized as a Class I event by the Food and Drug Administration.
- The company has received reports of seven serious injuries and one death related to software issues that could cause under- or over-infusion and delays in the delivery of critical medicines.
- The medtech firm is advising users of the 118,055 recalled devices to ensure an additional pump is available if an interruption to infusion could be dangerous. Smiths Medical plans to fix the issues with software updates.
Smiths Medical sent an Urgent Medical Device Correction letter to customers in April, according to the FDA. The letter warned that the Medfusion 3500 and 4000 syringe infusion pumps suffer from eight potential software issues. Some of the problems affect all versions of the 3500 and 4000 pumps, while others are limited to subsets of the devices.
The letter describes each of the eight issues and the actions customers should take in response to them. For most of the issues, Smiths Medical is advising users to take corrective actions or avoid certain modes and steps, while in one case the company is asking customers to return the affected devices.
Smiths Medical is asking customers to return devices if abnormal circuit board behavior causes the pump to stop. Medfusion 3500 and 4000 pumps with certain serial numbers may contain the circuit boards, which can delay or interrupt therapy and thereby lead to serious harm or death. As of April 19, Smiths Medical said it hadn’t received reports of injury or death linked to the issue, but it did ask affected users to send their pumps for service.
Three issues account for the seven serious injuries and one death, according to the FDA notice. Two patients suffered serious injuries and one died after a false alarm for system failure. The pump stops the active infusion in the event of a system failure alarm. Unanticipated depleted battery alarms led to four serious injuries. The seventh serious injury occurred when a pump continued running after a system failure.