Smiths Medical has amended an urgent medical device recall that it first issued in August for its Medfusion syringe pump model series 3500 and 4000.
After acknowledging that a defect in certain models of the pump can cause an “invalid syringe size” alarm to go off, the company added an option for facilities with trained staff to perform the repair onsite.
In August last year, Smiths reported that the thread lock material used on a fastening screw in its Medfusion pumps can be ineffective, causing the pump syringe barrel clamp mechanism to loosen. This prevents the pump from accurately detecting the diameter measurement of the syringe barrel, triggering the “invalid syringe size” alarm.
The alarm can delay an infusion from starting or interrupt an active infusion, which can result in serious injury or even death. But Smiths pointed out that it has not received any reports of deaths or serious injuries due to the pump’s alarm issue.
“Although no serious injuries or deaths have been reported as a result of this issue, Smiths Medical recommends against using the affected devices until repair work is completed or that you ensure your device does not present with this alarm on start-up before using it and monitor for alarms during use,” the company wrote.
In its amended recall notice, Smiths noted that facilities with biomedical departments can contact the company to retrieve the necessary parts and instructions to complete the pump repairs onsite.