SARNS 8000 PERFUSION SYSTEM
Received Mar 9, 2016
Report 1828100-2016-00165 · MDR key 5489201
Device
Generic name
Detector, Bubble, Cardiopulmonary Bypass-sarns 8000
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
(B)(4). THIS COMPLAINT IS RELATED TO EMDR #182810-2016-00164. THE FSR REPLACED THE LATCH ASSEMBLY AND PREVENTIVE MAINTENANCE/INSPECTION WAS COMPLETED SUCCESSFULLY. THE UNIT OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. THE SUSPECT PART WAS RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A FOLLOW-UP EMDR WILL BE FILED ACCORDINGLY.
Description of Event or Problem
THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) OF THE DEVICE (REFER TO EMDR #1828100-2016-00164), HE FOUND THE ULTRASONIC AIR SENSOR (UAS) LATCH ASSEMBLY WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.