S5 BUBBLE DETECTOR
Received Apr 12, 2017 · Event occurred Mar 27, 2017
Report 9611109-2017-00290 · MDR key 6485817
Device
Generic name
Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass
Manufacturer
Livanova DeutschlandModel number
23-07-50Product problems
- False Alarm
- Pumping Stopped
- False Alarm
- Pumping Stopped
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
PATIENT INFORMATION WAS NOT PROVIDED. LIVANOVA (B)(4) MANUFACTURES THE S5 BUBBLE DETECTOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF LIVANOVA (B)(4). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE TESTED THE DEVICE EXTENSIVELY AND WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. FUNCTIONAL VERIFICATION TESTING WAS SUCCESSFULLY COMPLETED AND THE DEVICE WAS RETURNED TO SERVICE. AS THE ISSUE COULD NOT BE REPRODUCED, A ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE.
Description of Event or Problem
LIVANOVA (B)(4) RECEIVED A REPORT THAT THE S5 BUBBLE DETECTOR GAVE REPEATED FALSE ALARMS AND TRIGGERED MULTIPLE PUMP STOPS DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SPARE SENSOR. THERE WAS NO PATIENT INJURY.
Remedial action
- Other