There was no patient involvement.
Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.
The incident occurred in (b)(6).
A livanova field service representative was dispatched to the facility to investigate the device and experienced a drive unit error code associated to a discrepancy between the set value and actual value of pump rpm.
A loan device was provided to the customer.
The affected device has been requested back to the manufacturer site for investigation.
If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
|