SARNS 8000 MODULE PERFUSION SYSTEM
Received Dec 25, 2016 · Event occurred Nov 30, 2016
Report 1828100-2016-00814 · MDR key 6203715
Device
Generic name
Detector, Bubble, Cardiopulmonary Bypass-sarns 8000 Perfusion System
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
5773Catalog number
5773
Product problems
- Break
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
PER THE FIELD SERVICE REPRESENTATIVE (FSR) THERE IS NO PART LEFT TO RETURN, THEREFORE NO PART WILL BE RETURNED TO THE MANUFACTURER FOR FURTHER ANALYSIS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.
Additional Manufacturer Narrative
THE REPORTED COMPLAINT WAS CONFIRMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.
Additional Manufacturer Narrative
(B)(4). FIELD SERVICE REPRESENTATIVE REMOVED THE ULTRASONIC AIR SENSOR (UAS) BROKEN LATCH AND INSTALLED A NEW LATCH. THE UAS SENSOR PASSED RELEASE TESTING. THE PREVENTIVE MAINTENANCE (PM) WAS COMPLETED SUCCESSFULLY, AND THE UNIT IS READY FOR CLINICAL USE. THE SUSPECT PART WILL BE RETURNED TO THE MANUFACTURER.
Description of Event or Problem
THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) OF THE DEVICE, THE ULTRASONIC AIR SENSOR (UAS) LATCH WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.