BUBBLE SENSOR DETECTOR
Received Feb 16, 2024 · Event occurred Jan 18, 2024
Report 9611109-2024-00080 · MDR key 18719037
Device
Generic name
Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass
Manufacturer
Livanova DeutschlandModel number
23-07-50Product problems
- Low Readings
- Low Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE BUBBLE SENSOR DETECTOR. THE INCIDENT OCCURRED IN RICHARDSON, TEXAS. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. H3 OTHER TEXT : DEVICE WILL BE INSPECTED BY CUSTOMER ENGINEER.
Description of Event or Problem
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A BUBBLE SENSOR DETECTOR MALFUNCTIONED DURING PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE. IT CANNOT BE EXCLUDED THAT BUBBLE SENSOR DID NOT DETECT AIR BUBBLE. THERE WAS NO PATIENT INJURY.
Additional Manufacturer Narrative
H10: DESPITE SEVERAL ATTEMPTS, LIVANOVA WAS NOT ABLE TO RETRIEVE ADDITIONAL INFORMATION REGARDING THE BUBBLE SENSOR MALFUNCTION FROM THE CUSTOMER. COMPLAINTS DATABASE ANALYSIS REVEALED NO SIMILAR EVENT SINCE UNIT INSTALLATION IN 2022.DUE TO THE LACK OF INFORMATION, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE ESTABLISHED AND REMAINS UNKNOWN.IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
SEE INITIAL REPORT.
Remedial action
- Other