MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Sep 13, 2013 · Event occurred Aug 1, 2013
Report 1828100-2013-00865 · MDR key 3396423
Device
Product problems
- Battery Problem
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
EVAL IS IN PROGRESS, BUT NOT YET CONCLUDED. THE CUSTOMER STATED THAT HE DIDN'T FEEL COMFORTABLE SHIPPING THE BATTERY TO THE MANUFACTURER BECAUSE IT HAD EVIDENCE OF A LEAK.
Description of Event or Problem
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE BATTERY WAS DEAD ON THE BLOOD PARAMETER MONITOR (BPM). AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PATIENT.