CAPIOX ARTERIAL FILTER

Additional Manufacturer Narrative

D4: UDI NUMBER FOR THIS PRODUCT CODE IS NOT REQUIRED. THE ACTUAL DEVICE HAS BEEN RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. THE ACCOUNT USED A TERUMO UK MADE TUBING PACK WITH THIS DEVICE. PRIOR TO BEING SENT TO THE ASHITAKA FACILITY TERUMO UK PERFORMED BLOOD PATHWAY TESTING. LEAKING OCCURRED ON BOTH THE INLET AND OUTLET DURING BLOOD PATHWAY TESTING WITH WATER AT 0.6BAR, 1/4X1/16 TUBING WAS ATTACHED AND CABLE TIED TO THE DEVICE. ONCE THE ACTUAL DEVICE WAS RECEIVED AT THE ASHITAKA FACILITY IT WAS VISUAL INSPECTED. NO ANOMALIES WHICH WOULD RELATE TO THE REPORTED LEAKS, IN THE APPEARANCE WAS NOTED. MAGNIFYING INSPECTION OF THE INLET PORT AND OUTLET PORT DID NOT REVEAL ANY ANOMALIES. EACH PORT WAS CONNECTED TO A 1/4" TUBE AND THE BLOOD PATHWAY WAS FILLED WITH SALINE SOLUTION. WITH THE BLOOD OUTLET PORT SIDE CLAMPED, THE BLOOD PATHWAY WAS PRESSURIZED AT AN AIR OF 1.6KGF/CM2 WHILE THE ACTUAL DEVICE WAS BEING OBSERVED FOR ANY LEAKAGE. NO LEAK WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT RELEASE DECISION CONTROL SHEET FROM THE REPORTED PRODUCT CODE/LOT NUMBER COMBINATION WAS CONDUCTED WITH NO RELEVANT FINDINGS. A SEARCH OF THE COMPLAINT FILE FOUND ONE OTHER REPORT WITH THE INVOLVED PRODUCT/LOT# COMBINATION. REFER TO MDR 9681834-2017-00222. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE INVESTIGATION RESULT VERIFIED THE ACTUAL SAMPLE WAS NORMAL PRODUCTS WITH NO LEAK AT ANY JOINTS. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

Description of Event or Problem

THE USER FACILITY REPORTED A LEAK IN THE CAPIOX DEVICE AFTER A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: DURING REWARMING A FEW DROPS OF BLOOD LEAKED FROM THE ARTERIAL FILTER PORT; EXTRA TIES STRAPS WERE PUT ON THE ARTERIAL FILTER CONNECTION TO STOP THE LEAKING; THE PROCEDURE WAS COMPLETED SUCCESSFULLY; AND THERE WAS NO HARM TO THE PATIENT.