MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE 8 M; OXYGENATOR, CARDIOPULMONARY BYPASS,

Model Number	050701
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H.11.Livanova manufactures the inspire 8 hollow fiber oxygenator.Livanova initiated an investigation.The involved device has been requested for return to sorin group italia for 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 has received a report that, during a procedure, two inspire oxygenators did not function as expected.Medical team elected to change out the first oxygenator (present case, livanova ref (b)(4)).With the second oxygenator, perfusionist elected to complete the case despite also the second oxygenator (livanova ref (b)(4)) was not functioning as expected.Livanova is submitting two differen initial manufacturer reports for the two complained oxygenators.There is no report of any patient injury.
Additional Manufacturer Narrative
B.3.: event date is july 30th, 2024.H.11: the customer has provided the perfusion protocol of the event.Analysis of the protocol identified a maximum peak of the trans-membrane pressure value (531 mmhg) was reached with a pump flow rate of 3,16 lpm.However, the initial arterial flow set was about 7,5 lpm suggesting the flow was lowered to compensate the arising high pressure.Following the peak, medical team elected to replace the oxygenator, the arterial zero flow condition (corresponding to the interruption of the procedure for the change-out of the oxygenator) lasted less than 2 minutes.After that the blood flow was correctly resumed.Through follow-up activity, livanova learned that no decay of the oxygenation performance occurred simultaneously with the increase of the pressure drop.The surgical phase when the oxygenator was replaced remains unknown.Returned oxygenator was returned to manufacturer and found significantly clogged.Despite an extensive cleaning operation was carried out, during preliminary step for subsequent functional testing, a restricted flow rate was reproduced due unwashable residue that obstructed the fibers.Therefore, no simulated functional test with bovine blood could be performed.Based on the available information, the reported event was traced back to the unexpected and progressive build up of biological material (platelet aggregates and fibrin mass) inside the oxygenator fibers that arose during the case at customer's facility.No manufacturing quality deviation possibly linked with the occurred phenomenon was established.Livanova conducted a literature and technical analysis about the trans-membrane oxygenator pressure gradients.Pressure drop excursion across the oxygenator is a known phenomenon reported in literature in all membrane oxygenators.The main cause of the pressure excursion has been identified in the platelet activation and adhesion within the oxygenator that progresses to increase resistance to blood flow during cardiopulmonary bypass.The factors influencing pressure excursions can be assigned to three main areas: - surgery clinical impact - cpb clinical impact - pathological patient conditions research on the phenomenon consistently concludes that the pressure excursion is complex and multi factorial and in most of the cases none of the factors considered singularly causes the phenomenon.An accurate analysis and monitoring of the factors identified can lead to the reduction of the phenomenon during cpb.Nevertheless at current state of knowledge the complex nature of the phenomenon does not allow its complete elimination.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.Since the change out lasted less than 3 minutes, according to livanova evaluation, the case has unlikely possibility to cause any patient injury, therefore the event has been reassessed as not reportable.
Event or Problem Description
See initial report.

• Brand Name: INSPIRE 8 M
• 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: 20198159
• Report Number: 9680841-2024-00024
• Device Sequence Number: 6674348
• Product Code: DTZ
• UDI-Device Identifier: 08033178112260
• UDI-Public: (01)08033178112260(17)251219(10)2212200095(240)050701
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201916
• 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): 11/18/2024

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: 12/19/2025
• Device Model Number: 050701
• Device Lot Number: 2212200095
• 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: 08/14/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2021
• 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