Medical device manufacturer, Terumo Cardiovascular Systems Corporation, has issued a medical device safety alert concerning its Terumo Advanced Perfusion System 1 – Air Bubble Detector (ABD) Sensor. The affected products are identified as follow:
A) Ultrasonic Air Sensor 3/8x3/32 [Catalogue Number: 5773]
B) Ultrasonic Air Sensor 1/4x3/32 [Catalogue Number: 5791]
C) Air Sensor 1/4x1/16 UAS BLK [Catalogue Number: 5785]
The manufacturer has identified a potential failure which could occur intermittently due to specific ABD that do not meet the manufacturer's specifications. Internal testing at the supplier, revealed that a crimped wire was placed into an ABD sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. Through further analysis it was found that the wire being placed into the connector housing backwards was a workmanship issue isolated to one operator at the supplier. This intermittent connection may result in false air bubble alarms. There have been no user complaints related to this issue.
The immediate and long-range health consequences that may result from use of or exposure to a falsely alarming ABD sensor are related to when the effects of the defective ABD sensor are noted. A failure of the ABD sensor which results in the inability to reset the safety system during initial cardiopulmonary bypass (CPB) system set up until the ABD sensor is replaced could result in risks associated with delay of the procedure. If the falsely alarming ABD sensor presents while supporting a patient on CPB, the range of severity and the risk of harm are those related to the duration of the interruption of arterial blood flow to the patient. This would be the time required for the perfusionist to diagnose whether it is a valid or false alarm condition, then mitigate the ABD sensor alarm situation by disabling the ABD system and resuming CPB while obtaining a back-up ABD sensor. All patient populations undergoing cardiopulmonary bypass, with the assistance of a Terumo System 1 which contains an affected ABD sensor, are at potential risk as a result of exposure to the fault condition.
The manufacturer is removing the affected ABD sensors from the field. Affected users will be contacted by the manufacturer to coordinate the shipment of a replacement device and subsequent return of the affected unit. The replacement ABD sensor supplied by the manufacturer will be part of a kit containing a cable and a bracket which are not affected by this removal. The cable and the bracket do not require replacement. Affected users can continue to use the ABD sensor while waiting for a replacement.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 1 September 2020