CAPIOX CARDIOPLEGIA

Additional Manufacturer Narrative

D4: UDI NO: N/A AS THIS PRODUCT CODE IS BULK PRODUCT. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E1: PHONE NUMBER: UNKNOWN. E2: HEALTH PROFESSIONAL: UNKNOWN. E3: OCCUPATION: UNKNOWN. NO ACTUAL DEVICE WAS RETURNED. CONFIRMATION OF THE PROVIDED IMAGE: LEAKS WERE OBSERVED FROM THE CONNECTION BETWEEN THE BLOOD INLET PORT AND THE TUBE. SIMULATION TEST: FROM THE PROVIDED IMAGE, SINCE IT WAS THOUGHT THAT THERE WAS A PROBLEM WITH ATTACHMENT OF THE SECURING TIE AND CONNECTION OF THE TUBE AS ONE OF THE POSSIBILITIES, THE FOLLOWING TEST WAS CONDUCTED. WHEN THE SECURING TIE WAS ATTACHED WITH A FACTORY-RETAINED PRODUCT, A CIRCUIT CONSISTING OF THE TUBE WAS ASSEMBLED WHILE RAISING THE TUBE TO KEEP IT LIFTING, AND THE COLORED SALINE SOLUTION WAS CIRCULATED, RESULTING IN LEAKING. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL DEVICE: NO ANOMALY WAS FOUND. PAST COMPLAINT FILE OF THE INVOLVED PRODUCE CODE AND LOT NUMBER: NO OTHER SIMILAR REPORT WAS FOUND. BASED ON THE INVESTIGATION RESULTS, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD OF THE ACTUAL DEVICE. AS THE CAUSE OF THIS CASE, BASED ON THE PROVIDED IMAGE AND THE SIMULATION TEST, IT WAS THOUGHT POSSIBLE THAT A PART OF THE TUBE WAS RAISED, CAUSING IT TO LIFT WHEN THE SECURING TIE WAS ATTACHED, BUT IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE. FOR FUTURE USE, PLEASE MAKE SURE THAT THERE IS NO LOOSENING IN EACH CONNECTION OF THE CIRCUIT WHERE THE CARDIOPLEGIA IS INCORPORATED BEFORE PRIMING. IN ADDITION, THE CAPS OF THE LURE PORTS CONNECTED TO OUR CARDIOPLEGIA MAY BECOME LOOSE DUE TO VIBRATION DURING TRANSPORTATION. THEREFORE, DURING USE, PLEASE ENSURE THAT LURE THERMISTOR AND THE CAPS ON ANY UNUSED LURE PORT ARE SECURELY TIGHTENED. TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

Description of Event or Problem

TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: THE CARDIOPLEGIA LEAKED. THE EVENT OCCURRED DURING PRIME. THE EVENT DID NOT RESULT IN DELAY WITH THE SURGICAL PROCEDURE, AND THE PRODUCT WAS NOT CHANGED OUT. THERE WAS NO PATIENT INJURY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.