D131 KIDS INFANT ARTERIAL FILTER

Additional Manufacturer Narrative

A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED D.4. THE D131 KIDS INFANT ARTERIAL FILTER IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE FILTER WAS ASSEMBLED. AS THE STERILE CONVENIENCE PACK IS NOT DISTRIBUTED IN USA, THE UDI NUMBER IS NOT APPLICABLE. G.5. THE COMPLAINED D131 KIDS INFANT ARTERIAL FILTER IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STAND-ALONE FILTER (CATALOGUE NUMBER 050542) IS REGISTERED IN THE USA (510(K) NUMBER: K072308). H.4. THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE FILTER WAS ASSEMBLED. H.11. LIVANOVA MANUFACTURES THE FILTER. THE INCIDENT OCCURRED IN FINLAND. REPORTEDLY, THE EVENT OCCURRED IN THE MIDDLE OF THE PROCEDURE AND NO PROBLEM WAS OBSERVED IN THE CIRCUIT BEFORE STARTING THE CASE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

SORIN GROUP ITALIA RECEIVED REPORT THAT, DURING PROCEDURE, THE ARTERIAL FILTER WAS FOUND TO BE CRACKED AND BLOOD LEAKAGE OCCURRED. REPORTEDLY, THE FILTER WAS BYPASSED AND THE OPERATION CONTINUED WITHOUT ANY OTHER PROBLEM. THERE WAS NO PATIENT INJURY.