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

Model Number	6F PH.I.S.I.O.
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information were not provided.Sorin group italia manufactures the inspire 6f hollow fiber oxygenator.The incident occurred in (b)(4).During follow up with the customer it was clarified that oxygenator was changed-out during the bypass and the change-out lasted more than 3 minutes.In addition, blood oxygen values before change-out were 32mmhg.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.Device not yet returned.
Event or Problem Description
Sorin group italia has received a report that, during a procedure using an inspire 6f oxygenator, the oxygen values in the patient blood were low.There is no report of any patient injury.
Event or Problem Description
See intial report.
Additional Manufacturer Narrative
Livanova has received a report regarding performance issue related to gas exchange with the oxygenator inspire 6f.Reportedly there was no patient impact.Abg report at 100% of fio2 has been provided and confirmed the reported issue showing po2 = 97 mmhg.The complained inspire oxygenator was returned to livanova for investigation after gamma-ray decontamination as per livanova internal procedure on blood contaminated goods.Settings of performance test were defined simulating the reported clinical conditions.However, in early phase, foaming process suddenly developed leaking out from capno-port.Such a behavior was assigned to extended hydrophilization of the oxy fiber and plasma breakthrough in gas side which resulted in plasma leakage and prevented any further analysis of gas exchange performances.As per collected evidence, it is possible to conclude that conditions of returned device did not allow to achieve any significant test results.Review of complaints database showed no further similar cases notified for batch concerned from the market, this excludes any possible quality issue related to manufacturing.Verification of dhr confirmed that the complained unit was released as conform according to specifications.Based on all the above facts, it is reasonable to conclude that the most likely root cause of reported failure was a multifactorial issue, resulting from the interaction between clinical procedure, patient conditions and initial gas-blood settings.The presence of shunted area across microporous hollow fiber oxygenator membrane cannot be excluded as contributing factor.In the event of undesired cellular activation associated with platelet adhesion and fibrin layer deposition inside the oxygenator, biological deposits may coat the fiber bundle capillaries in which the blood flows thus hindering the passage of o2.All this leads to a reduction of effective area to perform gas exchange and a concomitant increase of gas pathway length to perform gas exchange.The risk is in the acceptable region.No specific action was currently deemed necessary, livanova will keep monitoring the market.

• Brand Name: INSPIRE 6F HOLLOW FIBER OXYGENATOR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola
• Manufacturer (Section G): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 14117000
• Report Number: 9680841-2022-00022
• Device Sequence Number: 4334486
• Product Code: DTZ
• UDI-Device Identifier: 08033178112376
• UDI-Public: (01)08033178112376(17)241116(10)2111180001(11)211118(240)050715
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K120185
• 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): 09/08/2022

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: 11/16/2024
• Device Model Number: 6F PH.I.S.I.O.
• Device Catalogue Number: 050715
• Device Lot Number: 2111180001
• 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: 03/20/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown