SARNS 8000 MODULE PERFUSION SYSTEM
Received Oct 27, 2017
Report 1828100-2017-00491 · MDR key 6984175
Device
Generic name
Detector, Bubble, Cardiopulmonary Bypass-sarns 8000 Perfusion System
Manufacturer
Terumo Cardiovascular Systems CorporationModel number
149673Catalog number
149673
Product problems
- False Alarm
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). AS PER THE FIELD SERVICE REPRESENTATIVE (FSR), THE ABD WAS CLEANED AND THE CONNECTION TO THE SAFETY MONITOR WAS TIGHTENED. THE UNIT OPERATED TO THE MANUFACTURER'S SPECIFICATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.
Description of Event or Problem
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE AIR BUBBLE DETECTOR (ABD) KEPT ALARMING. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.