S5 DOUBLE HEAD PUMP

Additional Manufacturer Narrative

INVOLVED PUMP RACEWAY AND ALSO PUMP OCCLUSION WERE CHECKED (PRE-CASE CHECKLIST) BY THE CUSTOMER BEFORE MOUNTING THE TUBE. A DEVICE SERVICE HISTORY REVIEW HAS BEEN PERFORMED AND IDENTIFIED THAT THE UNIT WAS MANUFACTURED IN 2013 AND NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED. BASED ON THE COLLECTED INFORMATION, THE CAUSE OF THE REPORTED EVENT HAS BEEN TRACED BACK TO A DEFECTIVE GUIDE ROLLER DUE TO WEAR. THE WEARING OF ELECTRO-MECHANICAL DEVICES CAN BE ORIGINATED BY THE SPECIFIC USE CONDITION AT CUSTOMER SITE THAT MAY HAVE CONTRIBUTED TO THE EVENT, SUCH AS MOVEMENTS OR LIQUIDS PENETRATION. HOWEVER, THERE IS NO CONCERNING TREND FOR THIS KIND OF FAILURE. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

Description of Event or Problem

SEE INITIAL REPORT.

Description of Event or Problem

SEE INITIAL REPORT.

Additional Manufacturer Narrative

D.4 ADDITIONAL UNIQUE DEVICE IDENTIFIER (UDI) NUMBER IS NOT AVAILABLE FOR THIS PRODUCT AS IT IS A CLASS II MEDICAL DEVICE MANUFACTURED BEFORE SEPTEMBER 24, 2016 WHICH IS THE FDA COMPLIANCE DATE TO IMPLEMENT UDI CODE. H11: A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND COULD CONFIRM THE REPORTED ISSUE. THE DAMAGED ROLLER GUIDE HAD BEEN REMOVED. THE INSIDES OF THE DEVICE WAS CHECKED FOR BLOOD CONTAMINATION AND ONLY THE INNER CASING HAD DRIED BLOOD WITHIN. THIS WAS CLEANED AND A NEW DOUBLE ROLLER PUMP 85 HEAD FITTED AGAIN THROUGH BLOOD CONTAMINATION. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT DURING CARDIOPLEGIA ADMINISTRATION IT WAS NOTICED BLOOD WELLING UP IN THE BLOOD PUMP RACEWAY OF A S5 DOUBLE HEAD PUMP. AFTER THE FULL ARREST DOSE WAS ADMINISTERED, IT WAS DISCOVERED THAT ONE OF THE PLASTIC TIPS FROM THE GUIDE ROLLERS HAD FRACTURED RESULTING IN A PIECE OF PLASTIC PIERCING THE TUBING. THE DEFECTIVE PUMP MODULE WAS SWAPPED OUT, AND THE LEAKING TUBING REPLACED WITH 1/4 " TUBING AND APPROPRIATE CONNECTORS USING ASEPTIC TECHNIQUE. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. H11: LIVANOVA DEUTSCHLAND MANUFACTURES THE S5 DOUBLE HEAD PUMP. THE INCIDENT OCCURRED IN (B)(6). THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT THE DISPOSABLE USED BY THE CUSTOMER WAS A LIVANOVA PRODUCT. IN DETAIL, THE DISPOSABLE USED FOR THIS CASE WAS A VANGUARD CARDIOPLEGIA SET. IN ADDITION, INVOLVED PUMP RACEWAY AND ALSO PUMP OCCLUSION WERE CHECKED (PRE-CASE CHECKLIST) BY THE CUSTOMER BEFORE MOUNTING THE TUBE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.