CAPIOX ARTERIAL FILTER

Additional Manufacturer Narrative

D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G5: 510K - K943917 THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED A CRACK HAD BEEN GENERATED ON THE BLOOD INLET PORT. SALINE SOLUTION WAS LET TO FLOW THROUGH THE ACTUAL DEVICE. THE SALINE SOLUTION LEAKED AT THE CRACK. THE OUTSIDE AND INSIDE DIAMETERS OF THE BLOOD INLET PORT WERE MEASURED AT A POINT ADJACENT TO THE CRACK. THEY WERE CONFIRMED TO BE COMPARABLE TO THOSE OF THE CURRENT PRODUCT SAMPLE. A FACTORY-RETAINED SAMPLE OF THE INVOLVED PRODUCT CODE WAS HIT ON THE BLOOD INLET PORT WITH A HAMMER. THE BLOOD INLET PORT WAS EXPOSED TO INTENSIVE SHOCK FORCE, RESULTING IN THE GENERATION OF A CRACK WHICH WAS SIMILAR TO THAT OBSERVED ON THE ACTUAL SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD AND SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION REVEALED NO FINDINGS. IFU STATES: DO NOT ADD EXCESSIVE SHOCK TO THE FILTER, SUCH AS TAPPING WITH FORCEPS, DURING PRIMING OR BYPASS, AS THIS COULD DAMAGE THE PRODUCT. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. BASED ON THE INVESTIGATION, IT IS LIKELY THAT THE ACTUAL DEVICE WAS SUBJECTED TO SHOCK FORCE ON THE BLOOD INLET PORT AND GOT CRACKED, RESULTING IN THE REPORTED LEAK OF THE PRIMING SOLUTION. 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.

Description of Event or Problem

THE USER FACILITY REPORTED THAT PRE-TREATMENT AFTER THE CAPIOX CUSTOM PACK CIRCUIT WAS SET ON THE HLM; DURING PRIMING, WHEN THE CUSTOMER HIT THE ACTUAL SAMPLE WITH A HAMMER, THE PRIME STARTED TO LEAK. IT WAS FOUND THAT THE ACTUAL SAMPLE FOUND A CRACK ON THE BLOOD INLET PORT.