SARNS 8000 PERFUSION SYSTEM
Received Oct 23, 2015 · Event occurred Sep 30, 2015
Report 1828100-2015-00907 · MDR key 5171591
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 Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THE FIELD SERVICE REPRESENTATIVE (FSR) CONFIRMED THE BROKEN DRAW LATCH. HE REPLACED THE DRAW LATCH ASSEMBLY AND TESTED OPERATION SATISFACTORY. 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 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, THE DRAW LATCH ON ULTRASONIC AIR SENSOR (UAS) BROKE. THE 8K WAS BEING SET-UP FOR A CASE THE NEXT DAY. THEY HAVE A SPARE UAS AND SWAPPED IT FOR THE ONE WITH THE BROKEN DRAW LATCH. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.