Smiths Medical issued an urgent field safety notice in Europe regarding its Medfusion 3500 and 4000 infusion pumps.
The company issued the letter to notify on eight potential issues with its pumps. The issues include false alarms, unanticipated depleted battery alarms and abnormal circuit board behavior causing internal clock system failure.
Additionally, issues with intermittent volume over time delivery mode means infusion may continue after system failure, while there are issues with the clearing of program volume delivered, incorrect bolus or loading dose time display and network configuration affecting pump communciations.
In total, across the eight potential issues laid out by Smiths Medical, the company has received seven reports of serious injury and one death, according to the notice.
Five of the eight potential problems with the Medfusion 3500 and 4000 infusion pumps have not resulted in reported injury or death to date. The three that have produced such reports are the false alarm for the primary audible alarm (PAA) system failure, the unanticipated depleted battery alarms and the intermittent volume over time delivery mode issue.
When notifications to the clinician are required, Medfusion pumps initiate an alarm with both visual and audible indicators. If the pump detects an issue with the audible portion of the alarm, a PAA system failure is triggered to activate a backup alarm. If PAA system failure occurs, the pump terminates any active infusion.
Under certain conditions, including excessive electrical interference, the pump may falsely detect a PAA system failure. If the issue occurs, the pump sounds and displays an audible and visual alarm. Delay in therapy or interruption could lead to serious harm or death depending on the patient’s condition. To date, Smiths Medical has received reports of two serious injuries and one death potentially related to the issue.
For the depleted battery issue, under certain conditions with excessive pump wireless network activity, the pump may enter a state where its smart lithium-ion battery pack — which powers the pump when disconnected from AC power — cannot provide its status to the pump.
If the pump is running on battery power and a battery communication timeout alarm occurs, the pump assumes the battery is depleted and issues an unexpected depleted battery alarm, leading to potential interruption or delay of therapy. To date, four serious injuries have been reported as potentially related to the issue.
When the pumps enter intermittent volume over time (IVOT) delivery mode, it allows for the specification of a delivery volume for a specific delivery time, after which delivery stops for a programmed interval, then the pattern recycles. If the system failure alarm occurs during the small window of time when the pump transitions from IVOT delay to IVOT delivery, the pump may continue to run without the ability to terminate infusion via the “Stop” or “Power” keys.
Failure of the pump to stop running in this condition could result in the over-delivery of medication, potentially leading to serious harm or death. Smiths Medical has received one report of serious injury potentially related to the issue.
