SARNS 8000 PERFUSION SYSTEM
Received Dec 14, 2015
Report 1828100-2015-01030 · MDR key 5295252
Device
Generic name
Detector, Bubble, Cardiopulmonary Bypass-sarns 8000
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
5773Catalog number
5773
Product problems
- Detachment Of Device Component
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
(B)(4). THIS COMPLAINT IS RELATED TO THE FOLLOWING FOR THE SAME ISSUE (DIFFERENT DEVICE) AT THE SAME USER FACILITY: MDR #1828100-2015-01028, MDR #1828100-2015-01029 AND MDR #1828100-2015-01031. THE FIELD SERVICE REPRESENTATIVE (FSR) REPLACED THE LATCH ON THE UAS AND THE UNIT OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. THERE WILL BE NO PART RETURN. 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
THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) OF THE DEVICE, THE ULTRASONIC AIR SENSOR (UAS) LATCH WAS MISSING. THE UAS WAS WRAPPED IN VELCRO. THERE WAS NO PATIENT INVOLVEMENT.