S3 BUBB DET SENSOR, LOW LEVEL II
Received Dec 4, 2019 · Event occurred Mar 16, 2018
Report 9611109-2019-00941 · MDR key 9408693
Device
Generic name
Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass
Manufacturer
Livanova Deutschland GmbhModel number
23-27-40Product problems
- Failure to Auto Stop
- Failure to Auto Stop
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA (B)(4) MANUFACTURES THE S3 BUBB DET SENSOR, LOW LEVEL II. THE INCIDENT OCCURRED IN (B)(6). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND HE COULD NOT CONFIRM THE REPORTED FAILURE. THE DEVICE WAS FOUND TO BE WORKING ACCORDING TO THE SPECIFICATIONS. FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE.
Description of Event or Problem
LIVANOVA RECEIVED A REPORT THAT THE MAIN PUMP ON S5 SYSTEM DID NOT STOPPED AT THE LEVEL SENSOR ALARM DURING PRIMING. THE USER TURNED OFF AND ON THE MAIN POWER OF THE SYSTEM AND THE ISSUE DISAPPEARED. THERE WAS NO PATIENT INVOLVEMENT.
Remedial action
- Other