MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	8M
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was not patient involvement.The age of the device was calculated as the time elapsed between device sterilization and the date of the event.Sorin group (b)(4)manufactures the inspire 8f hollow fiber oxygenator with integrated arterial filter and hardshell.The incident occurred in (b)(6).The involved device has been received at sorin group (b)(4) facilities for investigation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Sorin group (b)(4) has received a report that, prior to priming the heart lung machine and after cooler water test was started, perfusionist observed an abundance amount of condensation inside the tubing between inspire 8.The team elected to change out the oxygenator.The issue occurred prior to any patient involvement.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
Sorin group italia manufactures the inspire 8f hollow fiber oxygenator with integrated arterial filter and hardshell.The incident occurred in (b)(6).The returned inspire oxygenator has been submitted to leak test at the water compartment: no leak could be reproduced.Dhr verification did not reveal any relevant information related with the claimed defect.The complained batch was not involved in any other similar event.Livanova investigation could not reproduce the claimed leakage: no device related failure could be confirmed.Livanova believes the most probable explanation of the condensation experienced by the customer is ascribable to the formation of moisture inside the blood inlet collector of inspire oxygenator module.This is a known issue.To eliminate/reduce moisture formation, inspire ifu recommends beginning to flow gas when the bypass is starting.Livanova will keep monitoring the market for similar events.

• Brand Name: INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 9021070
• Report Number: 9680841-2019-00033
• Device Sequence Number: 2410900
• Product Code: DTZ
• UDI-Device Identifier: 08033178112260
• UDI-Public: (01)08033178112260(17)211025(10)1810260015
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K180448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2021
• Device Model Number: 8M
• Device Catalogue Number: 050701
• Device Lot Number: 1810260015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1