CAPIOX

Additional Manufacturer Narrative

E3: OCCUPATION: CLINICAL ENGINEER. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. A VISUAL INSPECTION OF THE ACTUAL SAMPLE, IN THE SAME CONDITION AS RECEIVED BY THE ASHITAKA FACTORY, REVEALED NO BREAKAGE OR OTHER ANOMALIES IN ITS APPEARANCE. THE ACTUAL SAMPLE WAS FILLED WITH PHYSIOLOGICAL SALINE SOLUTION AND PRESSURIZED AT 760MMHG. AS A RESULT, IT WAS CONFIRMED THAT THERE WAS NO LEAKAGE FROM THE BUBBLE TRAP AND NO ANOMALIES SUCH AS A POOR CONNECTION WERE DETECTED. THE MANUFACTURING HISTORY AND SHIPPING INSPECTION RECORDS FOR THE ACTUAL SAMPLE SHOWED NO ANOMALIES. THE PAST COMPLAINT FILE FOR THE SPECIFIED PRODUCT CODE AND LOT NUMBER SHOWS NO SIMILAR COMPLAINTS WERE RECEIVED. BASED ON THE INVESTIGATION RESULT, NO LEAKAGE WAS FOUND IN THE ACTUAL SAMPLE. SINCE NO ANOMALY WAS FOUND IN THE ACTUAL SAMPLE, THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: PRESSURE AT THE BLOOD INLET OF THE CAPIOX BUBBLE TRAP SHOULD NOT EXCEED 760 MMHG. PRESSURES GREATER THAN 760 MMHG MAY CAUSE LEAKS OR DAMAGE TO THE DEVICE. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

Description of Event or Problem

THE USER FACILITY REPORTED THAT WHILE PRIMING, A SMALL LEAK WAS DETECTED IN THE WHITE RESIN PART OF THE BUBBLE TRAP (BT05X). THE COMPONENT WAS REPLACED WITH A NEW ONE, AND THE OPERATION WAS SUCCESSFULLY COMPLETED. THE EVENT OCCURRED PRE-TREATMENT. NO PATIENT INVOLVEMENT.