MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 7M HOLLOW FIBER OXYGENATOR

Catalog Number 050726

Device Problem Increase in Pressure (1491)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/22/2021

Event Type  Death  

Manufacturer Narrative

Patient information were not provided.The expiration date refers to the sterile finished product.The complained inspire 7 start oxygenator (catalog number 050726, lot 2104290006) is not distributed in the usa, therefore the udi is not applicable.The oxygenator item 050726 is similar to the inspire 7 oxygenator 050725, which is distributed in the usa, for which the device identifier is (b)(4).The product item 050726 is not distributed in the usa, but it is similar to the inspire 7 oxygenator item 050725, which is distributed in the usa (510(k) number: k190690).The device manufacture date refers to manufacture date of the sterile, finished oxygenator.Sorin group (b)(4) manufactures the inspire 7 start hollow fiber oxygenator.The incident occurred in (b)(6).The involved device has been requested for return to sorin group (b)(4) for investigation and received on 23/08/2021.The device has been sent to gamma ray decontamination on 31/08/2021, as per livanova procedure.During follow up with the customer, following information were received: event occurred on (b)(6) 2021 and patient died on (b)(6) 2021 patient had critical clinical history.On-going surgery was an aortic arch replacement (redo surgery).Three different by-pass times have been identified, change-out of the oxygenator was likely done during first by-pass time.No decay in overall gas exchange performances of the unit/s has been identified.Act times were maintained below 450 seconds during by-pass.Pump sheet has been received at livanova.Device under investigation in correlation with pump sheet information.In accordance with medical assessment performed by livanova clinical team, the reported low performance is well known issue reported in literature due to platelets adhesion.Oxygenator replacement is requested in case of low performance and in the reported event the replacement has not been performed.3 bypass occurred during surgery and time between each other is quite long and could increase the adhesion.The reported clinical condition was very critical surgery with high risk of mortality.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Sorin group (b)(4) has received a report that, at the begin of an extra-corporeal circulation procedure, progressive increased transmembrane pressure was observed during use of an inspire 7 start p oxygenator.According to customer, also a decrease of oxygenator performance was observed.The patient died on (b)(6) 2021.

Manufacturer Narrative

Livanova received a report about increased transmembrane pressure during surgery using a inspire 7 oxygenator.After pressure increase, customer reported a decay in overall gas-exchange performance levels, which required the change-out of the oxygenator.Event occurred on (b)(6) 2021 and patient died on (b)(6) 2021.Complained oxygenator was returned to livanova for investigation.Visual inspection of the returned oxygenator found clotted blood inside fiber bundle.To remove observed biological material, blood compartment was extensively washed and functional test with bovine blood was performed.Device was tested as per design specifications and relevant uni en iso.No resistance to blood flow causing any increased transmembrane pressure and no decay in gas transfer outcome could be reproduced during laboratory test: the oxygenator behaved as expected.Verification of manufacturing records confirmed that involved device was released as conform according to specifications.Review of complaints database revealed no other similar event notified for batch concerned.During follow up information with the customer, on (b)(6) 2021, livanova has been informed that: 1) the change-out of the oxygenator occurred at the 3rd bypass time.2) during last bypass time, gas flow rate set by perfusionist was raised to 4 lpm with fio2 adjusted to 98% while the average blood flow rate was increased to 3,5 lpm.This occurred after changing out the oxygenator.Since no device malfunction could be reproduced, the claimed malfunction is not confirmed and no correlation between patient outcome and any device issue can be confirmed.Considering all the above information, a possible explanation of the reported increased transmembrane pressure is related to the deposition of biological material during the phases between the by-pass procedures (3 by-passes, no issue reported during the first two).Since no device malfunction can be confirmed, no specific action was deemed necessary.Livanova will maintain monitoring the market for similar events.

Event Description

See initial report.

• Brand Name: INSPIRE 7M HOLLOW FIBER OXYGENATOR
• Type of Device: OXYGENATOR
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola
• MDR Report Key: 12420000
• MDR Text Key: 269720641
• Report Number: 9680841-2021-00025
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2024
• Device Catalogue Number: 050726
• Device Lot Number: 2104290006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death