SARNS ULTRASONIC AIR SENSOR
Received Mar 1, 2017 · Event occurred Feb 7, 2017
Report 1828100-2017-00104 · MDR key 6369985
Device
Generic name
Detector, Bubble, Cardiopulmonary Bypass-bubble Detector
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 FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE DEVICE AND INSTALLED A NEW LATCH ASSEMBLY. UAS IS WITHIN MANUFACTURER'S SPECIFICATIONS AND IS READY FOR CLINICAL USE. 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 (CPB), THE LATCH ON THE ULTRASONIC AIR SENSOR (UAS) WAS BROKEN. THE DEVICE WAS NOT CHANGED OUT AS THE CUSTOMER USED TAPE TO KEEP THE SENSOR LATCH CLOSED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.