BUBBLE SENSOR DETECTOR
Received Apr 11, 2023 · Event occurred Mar 13, 2023
Report 9611109-2023-00156 · MDR key 16711475
Device
Generic name
Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass
Manufacturer
Livanova DeutschlandModel number
23-07-50Product problems
- Over-Sensing
- Low Readings
- Over-Sensing
- Low Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A BUBBLE SENSOR DETECTOR WAS DEFECTIVE. THE ISSUE OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. IT CANNOT BE EXCLUDED THAT BUBBLE SENSOR DID NOT DETECT AIR BUBBLE.
Additional Manufacturer Narrative
A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE BUBBLE SENSOR DETECTOR. THE INCIDENT OCCURRED IN COTTBUS, GERMANY. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Additional Manufacturer Narrative
H10: THROUGH FOLLOW-UP COMMUNICATION WITH LIVANOVA FIELD SERVICE REPRESENTATIVE, IT WAS LEARNED THAT THE UNIT DETECTED AIR BUBBLES EVEN IF THERE WERE NO BUBBLES. IN CASE OF BUBBLE SENSOR TRIGGERING FALSE BUBBLE ALARMS, THE PUMP IS STOPPED BY THE BUBBLE ALARM EVEN IF NO AIR IS PRESENT IN THE MONITORED LINE. IN SUCH SITUATIONS, THE ALARM CAN ALWAYS BE CLEARED/OVERRIDDEN BY USER, ONCE THE LINE IS VERIFIED TO BE FREE OF AIR, AND THE PERFUSION CAN BE EASILY RESTARTED. THUS, IT IS UNLIKELY THAT A FALSE BUBBLE ALARM WILL RESULT IN SERIOUS INJURY. THEREFORE, THE EVENT HAS BEEN RE-ASSESSED AS NOT REPORTABLE.
Description of Event or Problem
SEE INITIAL REPORT.
Remedial action
- Other