D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING

Description of Event or Problem

LIVANOVA USA INC HAS RECEIVED A REPORT THAT, DURING PRIMING OF A CIRCUIT, PARTICULATE MATTER WAS NOTICED NEAR THE BLOOD OUT CONNECTOR D731 MICRO 27 ARTERIAL FILTER. THE ISSUE OCCURRED PRIOR TO ANY PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

NO PATIENT INFORMATION HAS BEEN PROVIDED. THE D731 MICRO 27 ARTERIAL FILTER IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE ARTERIAL FILTER WAS ASSEMBLED. THE UNIQUE IDENTIFIER (UDI) NUMBER OF THE STERILE CONVENIENCE PACK IS (B)(4).G.5. THE INVOLVED D731 MICRO 27 ARTERIAL FILTER IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE STANDALONE D731 MICRO 27 ARTERIAL FILTER IS ALSO REGISTERED IN THE USA (510(K) NUMBER: K112525). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE D731 MICRO 27 ARTERIAL FILTER WAS ASSEMBLED. SORIN GROUP ITALIA MANUFACTURES THE D731 MICRO 27 ARTERIAL FILTER. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP ITALIA FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT YET RECEIVED.

Additional Manufacturer Narrative

D.9. LIVANOVA WAS INFORMED THE DEVICE HAS BEEN DISPOSED OFF. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

SEE INTIAL REPORT.

Description of Event or Problem

SEE INITIAL REPORT.

Additional Manufacturer Narrative

LIVANOVA RECEIVED A REPORT STATING THAT, DURING PRIMING, A MOBILE PLASTIC PARTICLE WAS OBSERVED COMING FROM THE ARTERIAL FILTER. A CLEAR PICTURE WAS PROVIDED AS EVIDENCE OF THE DEFECT, SHOWING AN EXCESS OF MATERIAL AT THE END OF THE ARTERIAL FILTER CONNECTOR. THE INVOLVED DEVICE IS MANUFACTURED BY EXTERNAL LIVANOVA ASSEMBLER (MEDIPRO). THE REVIEW OF THE SIMILAR EVENTS HIGHLIGHTED ANOTHER COMPLAINT ON THE SAME FILETR THUS, THE FAILURE RATE IS 0,14. HOWEVER, AS NO OTHER SIMILAR EVENTS HAVE BEEN REGISTERED IN THE LAST YEAR, IT CANNOT BE RULED OUT A DEVIATION LOT-RELATED. THE UNIT WAS NOT AVAILABLE FOR FURTHER INVESTIGATION BECAUSE THE CUSTOMER THREW IT AWAY. BASED ON THE FACTS ABOVE AND WITH THE INFORMATION AVAILABLE, IT CANNOT BE RULED OUT THAT THE ORIGIN OF THE PARTICULATES WAS RELATED TO A DEVIATION DURING THE MOULDING PHASE OF THE CONNECTOR. THE SCENARIO WAS FURTHERLY ENHANCED BY SUBSEQUENT INEFFECTIVE VISUAL CONTROLS SINCE THE OBSERVED MATERIAL WAS NOT INTERCEPTED BEFORE PRODUCT RELEASE. NO OTHER SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY, LIVANOVA MAINTAINS AND DOCUMENT PERIODIC CUSTOMER EVENTS MONITORING PROCESS IN ORDER TO EVALUATE ACTIONS FOR PRODUCTS IMPROVEMENT.