ARTERIAL FILTER

Description of Event or Problem

THE USER FACILITY REPORTED THAT THE ARTERIAL FILTER LID HAD A BOND ISSUE. THE EVENT OCCURRED DURING PRIMING. THERE WERE NO SURGICAL DELAYS. THERE WAS NO BLOOD LOSS. IT WAS UNKNOWN IF THE SURGERY WAS SUCCESSFUL. THE PRODUCT WAS CHANGED OUT. THE EVENT DID NOT CAUSE OR CONTRIBUTE TO AN INJURY. ADDITIONAL INFORMATION WAS RECEIVED ON 10 NOV 2022: THERE WERE NO PATIENT ISSUES. THE ARTERIAL FILTER WAS EITHER CLAMPED OFF OR REPLACED AND SETUP RESUMED.

Additional Manufacturer Narrative

UDI: N/A, AS THIS PRODUCT CODE IS BULK PRODUCT. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. HEALTH PROFESSIONAL: UNKNOWN. INITIAL REPORTER OCCUPATION: UNKNOWN. THE ACTUAL DEVICE WAS NOT AVAILABLE; THEREFORE, THE ACTUAL DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL PRODUCT FOUND NO ANOMALY. NO OTHER SIMILAR REPORT WAS FOUND WITH THE PRODUCT OF THE INVOLVED PRODUCT CODE/LOT NUMBER. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORDS. SINCE THE ACTUAL SAMPLE COULD NOT BE CONFIRMED, THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. THE INSTRUCTIONS FOR USE (IFU) (CAPIOX ARTERIAL FILTER) OF ASHITAKA FACTORY HAS THE FOLLOWING CAUTION: "DO NOT USE IF THE PACKAGE AND/OR DEVICE IS DAMAGED (E.G., CRACKED), OR IF ANY OF THE PORT CAPS ARE OFF." (B)(4).