TERUMO CDI 100 MONITOR
Received Jun 25, 2014 · Event occurred Jan 1, 2014
Report 1828100-2014-00542 · MDR key 3966259
Device
Product problems
- Break
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE BLOOD PARAMETER MONITOR (BPM) WAS NOT ACCURATE. THIS ISSUE HAS OCCURRED A COUPLE OF TIMES AND EXACT DATES ARE UNK BY CUSTOMER. THE DEVICE WAS NOT CHANGED OUT, AS THE CUSTOMER USED A LAB ANALYZER TO FINISH THE CASE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCES TO THE PT. PER THE CLINICAL REVIEW ON (B)(6) 2014: AFTER CONSULTATION WITH THE CLINICAL TEAM, IT WAS DISCOVERED THAT THE CLIP ON THE H/SAT PROBE WAS BROKEN AND THE SECURITY OF THE PROBE TO THE CUVETTE WAS NOT IDEAL. THIS WOULD AT TIMES LEAD TO INACCURATE DATA (BOTH HEMATOCRIT AND SATURATION). THIS WAS FOUND BY THE PERFUSIONIST AND THE DATA WAS NOT USED TO CLINICALLY MANAGE THE PT. ADD'L LAB SAMPLES WERE TAKEN TO BETTER MONITOR AND MANAGE THESE VALUES. THE CASE WAS COMPLETED SUCCESSFULLY, WITHOUT DELAY AND WITHOUT ASSOCIATED BLOOD LOSS.
Additional Manufacturer Narrative
EVAL IS IN PROGRESS, BUT NOT YET CONCLUDED.