inforMED
MalfunctionKRL

S3 BUBBLE DETECTOR

Received Oct 11, 2019 · Event occurred Jan 18, 2018

Report 9611109-2019-00809 · MDR key 9178245

Device

Generic name

Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass

Model number

23-07-50

Product problems

  • False Alarm
  • False Alarm

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA (B)(4) MANUFACTURES THE S3 BUBBLE DETECTOR. THE INCIDENT OCCURRED IN (B)(6). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND THE CUSHIONS OF THE BUBBLE SENSOR WERE FOUND TO BE DEFLATED. THE SENSOR HAS BEEN REPLACED AND THE ISSUE SOLVED. A REVIEW OF THE DHR COULD NOT IDENTIFY ANY DEVIATIONS OR NONCONFORMITIES RELEVANT TO THE ISSUE.

Description of Event or Problem

LIVANOVA (B)(4) RECEIVED A REPORT THAT A PUMP STOP HAS BEEN TRIGGERED BY A BUBBLE ALARM. THE PERFUSIONIST WAS NOT ABLE TO START THE PUMP AGAIN AND RESUME THE BYPASS. THEREFORE, THE S3 BUBBLE DETECTOR WAS SWITCHED OFF AND THE PERFUSIONIST WAS ABLE TO START THE PUMP AGAIN. THERE WAS NO REPORT OF PATIENT INJURY.

Remedial action

  • Other