MalfunctionDTY
TERUMO CDI 101 MONITOR
Received Jul 20, 2012 · Event occurred Jun 26, 2012
Report 1828100-2012-01035 · MDR key 2670228
Device
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING PREPARATION OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE HEMATOCRIT/O2 SATURATION MONITORING CLIP WAS BROKEN. THE DEVICE WAS TAPED AND WAS NOT CHANGED OUT FOR THE PROCEDURE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT.
Additional Manufacturer Narrative
INVESTIGATION IN PROCESS, BUT NOT YET COMPLETE.