Terumo Corp. (TYO:4543) warned users of its Advanced Perfusion System 1, Sarns Modular Perfusion System 8000 and Sarns Perfusion System 9000 of possible malfunctions related to the devices’ air bubble detections systems.
The company has received "multiple reports" of false alarms generated by the air bubble warning system, although it’s a "highly unlikely" malfunction.
Should the system fail during cardiopulmonary bypass, however, it could lead to "temporary interruption of arterial blood flow, air entrainment in the system, or the need to continue the case with a disabled air sensor."
Stalled arterial blood flow could result in heart or brain damage or organ dysfunction if it continues long enough. A trapped air bubble could make its way into the patient’s body, possibly causing damage to the heart, brain and organs, stroke or death.
Terumo is not recommending turning off the air bubble detection systems, but is warning users to keep an eye out for real or false air alarms and to be aware of safety systems on the machines. The device maker is updating its operator’s manuals to alert users of the potential issue and "reinforce mitigation procedures in the event of a malfunction."
The company had received no reports of patient injury associated with the issue, according to the correction.
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