TERUMO CDI 100 MONITOR
Received Feb 14, 2013 · Event occurred Mar 9, 2012
Report 1828100-2013-00173 · MDR key 3004384
Device
Product problems
- Break
- Detachment Of Device Component
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
INVESTIGATION IN PROGRESS, BUT NOT YET COMPLETED.
Description of Event or Problem
IT WAS REPORTED THAT DURING PRIME OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE CLIP OF HEMATOCRIT SATURATION (HCT/SAT) PROBE FROM THE BLOOD PARAMETER MONITORING (BPM) SYSTEM HAD BEEN BROKEN OFF. PER THE CLINICAL REVIEW: THE USER REPORTED THAT THE HSAT PROBE OF THE BPM SYSTEM COULD NOT BE CLIPPED OR SECURED TO THE DISPOSABLE CUVETTE. SOME TROUBLESHOOTING WAS DONE AND THIS DID DELAY THE PREPARATION TIME OF THE CPB CIRCUIT, BUT LIKELY DID NOT DELAY THE START OF THE SURGICAL PROCEDURE. THE DEVICE WAS NOT CHANGED OUT, AS THE PERFUSIONIST USED ARTERIAL BLOOD GAS FOR BLOOD PARAMETER MONITORING. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PATIENT.