INSPIRE 7F M N/S

Additional Manufacturer Narrative

A1-A5 PATIENT INFORMATION WAS NOT PROVIDED. D.4. SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. G.5. THE PRODUCT ITEM 03735 IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE INSPIRE 7 FM 050729 WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K130209). H11 SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 7F M OXYGENATOR, THE EVENT OCCURRED IN CANADA. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

SORIN GROUP ITALIA RECEIVED A REPORT THAT THE OXYGENATOR INSPIRE 7F WAS CHANGED OUT DUE TO HIGH PRESSURE EXCURSION INSIDE THE MEMBRANE. NO PATIENT INJURY HAS BEEN REPORTED.

Additional Manufacturer Narrative

H11: THROUGH FOLLOW-UP COMMUNICATIONS, IT WAS LEARNED THAT THE OXYGENATOR CHANGE OUT TOOK LESS THAN 3 MINUTES. BASED ON THE ABOVE, THE EVENT WAS RE-ASSESSED AS NOT REPORTABLE, SINCE PERFUSION INTERRUPTIONS LASTING LESS THAN 3 MINUTES DUE TO OXYGENATOR FAILURE, WITHOUT ANY PATIENT IMPACT AND NO MEDICAL INTERVENTIONS, COULD NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY, EVEN IF RECUR.

Description of Event or Problem

SEE INITIAL REPORT.