SARNS 8000 PERFUSION SYSTEM
Received Jan 21, 2016 · Event occurred Dec 29, 2015
Report 1828100-2016-00026 · MDR key 5382868
Device
Generic name
Detector, Bubble, Cardiopulmonary Bypass-sarns 8000
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
149673Catalog number
149673
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THE REPORTED COMPLAINT WAS CONFIRMED. THE USER FACILITY¿S BIOMEDICAL ENGINEER (BIOMED) STATED THAT THE BROKEN LATCH WAS DISCARDED, THEREFORE NO PART WILL BE RETURNED. 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 PROCEDURE, THE RED ULTRASONIC AIR SENSOR (UAS) LATCH WAS BROKEN. THE DEVICE WAS NOT CHANGED OUT, AS THEY TEMPORARILY USED ADHESIVE TAPE TO SECURE THE UNIT. USING THIS METHOD OF SECURING, THE UNIT HAS BEEN SUCCESSFUL AND UNIT WAS FUNCTIONING PROPERLY. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.