TERUMO CDI 100 MONITOR
Received Sep 13, 2013 · Event occurred Apr 15, 2013
Report 1828100-2013-00866 · MDR key 3396396
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE A/D (ANALOG TO DIGITAL CONVERSION) TEST FAILED 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.
Additional Manufacturer Narrative
THIS COMPLAINT WAS CONFIRMED BY THE PRODUCT SURVEILLANCE LAB TECH. THE A/D (ANALOG TO DIGITAL CONVERSION) TEST FAILURE ERROR WAS OBSERVED AND WAS OCCURRED DURING THE POWER UP SELF-TEST. VISUAL INSPECTION FOUND A CRACKED BATTERY THAT HAD LEAKED ACID. THE BATTERY LEAKING WAS CONFIRMED TO HAVE REACHED THE PCBA. BATTERY ACID HAS DAMAGED THE CIRCUITS AND WAS PRESENT ON THE CIRCUIT BOARD. THE BATTERY ACID WAS CONSIDERED TO HAVE CAUSED THE A/D FAILURE ON THE PCBA. THIS PRODUCT IS BEING PHASED OUT IN THE GLOBAL MARKET. SERVICE AND REPLACEMENT PARTS ARE NO LONGER AVAILABLE. IF ADD'L INFO BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.