Medical device manufacturer, Medtronic Inc. has issued a Field Safety Notice concerning Pressure Display Box, model 66000, with disposable Pressure Display Set (Models 61000, 61006, 62000, 62006). The notice intended to inform users about the clarification related to the Directions of Use (DFU) provided with the product

According to Medtronic, the display reading of the Press Display Box may vary more than +/- 5mmHg from actual line pressure during use in the -40 to -100mmHg range, which is different from the figure stated in the DFU. Previous Pressure Display Boxes which may still be in use (models 60000, 63000 and 64000) 64000), do not include accuracy information beyond -50 mmHg for negative pressure in their DFU, but are expected to perform similarly to the model 66000.

Besides, Medtronic clarified that the intended use of the disposables is only for cardiopulmonary bypass surgery (procedures up to 6 hours). Use beyond 6 hours may result in air leakage in the system resulting in an inaccurate pressure reading.

Medtronic intends to update the Directions for Use (DFU) provided with the products to address the abovementioned issues.

According to the local supplier, the device has been distributed in Hong Kong, and they are in the process of notifying the affected customers.

For details, please refer to the attached Field Safety Notice. If you are in possession of the affected products, please contact your supplier for necessary actions.