TERUMO CDI 100 MONITOR
Received Feb 21, 2013 · Event occurred Jan 29, 2013
Report 1828100-2013-00232 · MDR key 2998873
Device
Product problems
- Melted
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 BATTERY MELTED TO THE BACK OF THE ENCLOSURE. THE DEVICE WAS NOT CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO BLOOD LOSS AND NO ADVERSE CONSEQUENCES TO THE PATIENT. PER THE CLINICAL REVIEW: ISSUE WITH "POWERING UP" THE CDI100 MONITOR DURING SET-UP FOR A PROCEDURE. THE ISSUE WAS NOT ABLE TO BE RESOLVED AND THE USER DID NOT USE THE DEVICE. THIS DELAYED THE SET-UP TIME, BUT DID NOT DELAY THE START OR ACTUAL SURGICAL PROCEDURE. THE PERFUSIONIST USED AN INDEPENDENT LABORATORY ANALYZER FOR INTERMITTENT SAMPLING TO GUIDE CLINICAL MANEUVERS.