TERUMO CDI 100 MONITOR
Received Nov 9, 2012 · Event occurred Sep 27, 2012
Report 1828100-2012-01412 · MDR key 2834847
Device
Product problems
- Smoking
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, SMOKE WAS OBSERVED COMING FROM THE UNIT'S EXTERNAL POWER SUPPLY. THE USER DISCONTINUED USE OF THE UNIT AND USED ANOTHER MODEL AND BRAND OF HEMATOCRIT AND OXYGEN SATURATION MONITORING. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT.
Additional Manufacturer Narrative
THE CUSTOMER WILL NOT BE RETURNING THE UNIT FOR REPAIR. IF ADD'L INFO BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.