MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Apr 29, 2013 · Event occurred Apr 1, 2013
Report 1828100-2013-00476 · MDR key 3098880
Device
Product problems
- Fracture
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
AFTER USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE HEMATOCRIT SATURATION (H/SAT) CABLE WAS FRACTURED. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PT.
Additional Manufacturer Narrative
EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED. UPON EVALUATION AT THE MANUFACTURER. FOUND SEVERE DAMAGE TO THE CABLE. INTERNAL WIRES ARE BROKEN AND CONDUCTORS ARE EXPOSED.