TERUMO CDI 100 MONITOR
Received Feb 10, 2015
Report 1828100-2015-00132 · MDR key 4511466
Device
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE BLOOD PARAMETER MONITOR (BPM) TOOK A LONG TIME TO POWER UP. THE DEVICE WAS NOT CHANGED OUT, AS THEY USED THE BPM FOR THE CASE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.
Additional Manufacturer Narrative
THIS COMPLAINT IS RELATED TO MDR #1828100-2015-00133. THIS HAS BEEN AN ONGOING ISSUE FOR THE PAST THREE MONTHS. THE REPORTED COMPLAINT WAS CONFIRMED. DURING INSPECTION OF THE BPM, IT WAS FOUND TO HAVE A DAMAGED BATTERY AND BATTERY ACID HAD LEAKED INTO THE UNIT EFFECTING THE UNIT TO POWER ON. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.