SARNS 8000 PERFUSION SYSTEM
Received Aug 5, 2016 · Event occurred Jul 14, 2016
Report 1828100-2016-00538 · MDR key 5849810
Device
Generic name
Detector, Bubble, Cardiopulmonary Bypass-sarns 8000
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
149673Catalog number
149673
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE RED ULTRASONIC AIR SENSOR (UAS) LATCH WAS BROKEN. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.
Additional Manufacturer Narrative
THE REPORTED COMPLAINT WAS CONFIRMED. PER USER FACILITY BIOMEDICAL ENGINEER (BIOMED), THE REPAIR TO THE RED ULTRASONIC AIR SENSOR (UAS) WAS COMPLETED. NO PART WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.