MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE 6F; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	050715
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.11.Livanova manufactures the inspire 6f.Livanova initiated an investigation.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 italia received a report of leakage in membrane side below water line connection of an inspire 6f oxygenator and poor oxygenation during procedure.There is no report of any patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
By follow-up communication, livanova received a video as evidence of the issue, showing the dripping of foamy blood from the bottom rear of the device.Specifically, blood was dripping from the open slot below the connection of the water lines to the water ports of the device.Submitter of the case was duly requested to confirm the surgical phase and time duration of the change out of the oxygenator andt no further details were made available.No negative consequences to the patient's health conditions were communicated.Review of the livanova complaints database highlighted that the batch concerned of product was not involved in any other similar incident.In addition, two blood gas reports were provided which were plausibly reflecting the complained low oxygenation condition experienced and the recovery scenario (reasonably after the change-out of the device).The blood gas report suggest that an improvement of the overall oxygenation performance was therefore established.Based on the above findings, the complained leakage pathway was confirmed and traced back to the presence of damaged fibers in the rear portion of the oxygenator: in this scenario, fluid (priming or blood) enters the ruptured capillary and leaks out of the gas escape compartment following the gas flow direction.The subsequent decay in the oxygenation levels ensured by the device was the result of the broken fibers that were no longer participating to the gas exchange effectively.Considering that 100% of the units in production line is subjected to a final leak test and that involved unit successfully passed the in-process check and no trend has been registered for similar case, it cannot be excluded that a fiber bundle capillary manufacturing variability with the contribution of thermal and/or transportation mechanical stress could have led to the observed breakage during use.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: INSPIRE 6F
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola
• Manufacturer (Section G): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola 80309 ; IT 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 21102481
• Report Number: 9680841-2025-00001
• Device Sequence Number: 8776028
• Product Code: DTZ
• UDI-Device Identifier: 38033178112377
• UDI-Public: (01)38033178112377(17)270927(10)2409270163(240)050715
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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 Model Number: 050715
• Device Lot Number: 2409270163
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 03/02/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown