SARNS 8000 PERFUSION SYSTEM
Received Feb 26, 2016
Report 1828100-2016-00128 · MDR key 5464225
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
THE FIELD SERVICE REPRESENTATIVE (FSR) RETURNED TO THE USER FACILITY TO REPLACE BACKORDERED AIR BUBBLE DETECTOR (ABD) DRAW LATCH AND CHECKED OPERATION. 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.
Additional Manufacturer Narrative
(B)(4). THE UABD LATCH IS ON BACKORDER, THE FSR WILL RETURN TO THE USER FACILITY WHEN THE LATCH IS AVAILABLE. PM INSPECTIONS ARE COMPLETE AND THE UNIT OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE.
Description of Event or Problem
THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) OF THE DEVICE, THE ULTRASONIC AIR BUBBLE DETECTOR (UABD) LATCH WAS BROKEN INTO TWO PIECES. THE FSR FOUND THE LATCH WAS TAPED TOGETHER. THERE WAS NO PATIENT INVOLVEMENT.