AF125 ARTERIAL FILTER

Additional Manufacturer Narrative

LOT NUMBER: REQUESTED, UNKNOWN. EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. DEVICE MANUFACTURE DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. SINCE THE PRODUCT CODE AND LOT NUMBER WERE UNKNOWN, IT WAS NOT POSSIBLE TO INVESTIGATE THE MANUFACTURING RECORDS. A SEARCH OF THE COMPLAINT FILE OF THE PAST TWO YEARS FOUND NO OTHER SIMILAR REPORT FOR CAPIOX ARTERIAL FILTER AF125X. (B)(4).

Description of Event or Problem

THE USER FACILITY REPORTED THAT THERE A SPLIT KEY THAT SEALED THE FILTER OUTLET ON THE CAPIOX ARTERIAL FILTER INVOLVED; THEREFORE, THE DEVICE WAS UNABLE TO PURGE, AND IT CLOSED THE AIR INLET TO THE CIRCUIT. THE EVENT OCCURRED PRE-TREATMENT. THE PROCEDURE OUTCOME WAS UNKNOWN. THE FINAL PATIENT IMPACT WAS NOT HARMED.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO UPDATE SECTION D9, SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS ACCORDING TO THE INFORMATION, THIS PPR IS THE COMPLAINT FOR CAPIOX ARTERIAL FILTER AF125X (CX AF125X OR ZZ AF125X). IF THE INVOLVED PRODUCT WAS CX AF125X, SINCE THE LOT NUMBER WAS UNKNOWN, ONLY DI NO. IS REPORTED. DI NO. (B)(4) IF THE INVOLVED PRODUCT WAS ZZ AF125X, UDI NO: N/A, AS THIS PRODUCT CODE IS BULK PRODUCT. SINCE THE PRODUCT CODE AND THE LOT NUMBER WERE UNKNOWN, IT WAS NOT POSSIBLE TO INVESTIGATE THE CASE. THE COMPLAINT FILE FOR PAST TWO YEARS, NO OTHER SIMILAR REPORT OF CAPIOX ARTERIAL FILTER AF125X WAS FOUND. SINCE THE ACTUAL PRODUCT AND THE MANUFACTURING RECORD COULD NOT BE INVESTIGATED, IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE OF OCCURRENCE. RELEVANT IFU REFERENCE: "DO NOT USE IF THE PACKAGE AND/OR DEVICE IS DAMAGED (E.G. CRACKED), OR IF ANY OF THE PORT CAPS ARE OFF."