TERUMO CDI 100 MONITOR
Received Sep 13, 2013 · Event occurred Apr 8, 2013
Report 1828100-2013-00877 · MDR key 3396422
Device
Product problems
- Power Problem
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 MONITOR WOULD SHUT DOWN UNIT. THE DEVICE WAS NOT CHANGED OUT, AS THE CUSTOMER RAN THE CASE WITHOUT HEMATOCRIT SATURATION MODULE (H/SAT). THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PATIENT.
Additional Manufacturer Narrative
THIS COMPLAINT WAS CONFIRMED BY LAB INSPECTION. THE UNIT'S BATTERY WAS CRACKED AND LEAKING INTERNAL FLUID LEADING TO THE CORROSION OF THE BATTERY COMPARTMENT. ACCORDING TO THE ANALYSIS, THIS PREVENTED THE UNIT FROM STARTING UP. THE UNIT WOULD START WHEN ASSOCIATED POWER SUPPLY WAS USED, WITH ALL MONITOR FUNCTIONS WORKING TO SPECIFICATION. SERVICE AND REPLACEMENT PARTS ARE NO LONGER AVAILABLE. NO ADD'L ACTION WILL BE TAKEN AT THIS TIME.