MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 7 HOLLOW FIBER OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	7 DUAL
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information were not provided.Device has not been requested for investigation sorin group (b)(4) manufactures the inspire 7 oxygenator.The incident occurred in (b)(6).If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.
Event or Problem Description
Sorin group (b)(4) has received a report that, at the beginning of a procedure, transmembrane pressure across an inspire 7 oxygenator increased over 300 mmhg.The gas exchanges performance were satisfying.The procedure was concluded without any issue.There is not report of any patient injury.On (b)(6) 2022, livanova received the pump sheet of the procedure and identified that 1mg of magnesium was administered to patient following transmembrane pressure increase.
Event or Problem Description
See intial report.
Additional Manufacturer Narrative
Livanova received a report of increased trans-membrane pressure across an inspire oxygenator 7 dual at the beginning of the surgery and 1 mg of magnesium was administered to patient soon after the increased trans-membrane pressure was detected.No gas exchange performances impact was reported.The procedure was completed with no issue.The customer has provided to livanova the pump sheet of the event.Analysis of provided pump sheet confirmed the increased trans-membrane pressure, the administration of the magnesium to the patient to tackle increased trans-membrane pressure and that the activated clotting time (act) values recorded concomitantly with the increased trans-membrane pressure were below 450 seconds.Ifu's of the inspire oxygenators recommend that the act must always be higher than or equal to 450 seconds to ensure adequate blood anticoagulation within the extracorporeal circulation system.Verification of manufacturing records confirmed that involved device was released as conform according to specification.Review of the livanova complaints database identified another similar event related to the same oxygenator lot.Based on the above and previous similar events, livanova believes the increased hydraulic resistance to passage of blood reported by customer was assigned to undesired cellular activation and buildup of biological material inside circuit due to platelet adhesion and fibrin layer deposition in oxy fibers.High pressure excursion event across oxygenator is a multifactorial phenomenon possibly affected by interaction of multiple contributing factors such as clinical procedure (e.G., surgical material), therapies (e.G., anticoagulant prescription, heparin composition and priming composition) and patient-specific health conditions.The risk is in the acceptable region.No action is deemed necessary.Livanova will keep monitoring the market.

• Brand Name: INSPIRE 7 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: livanova inc ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 14516609
• Report Number: 9680841-2022-00026
• Device Sequence Number: 17544067
• Product Code: DTZ
• UDI-Device Identifier: 08033178113236
• UDI-Public: (01)08033178113236(17)220822(10)1908230156(11)190823(240)050728
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K190690
• 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): 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/22/2022
• Device Model Number: 7 DUAL
• Device Catalogue Number: 050728
• Device Lot Number: 1908230156
• 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: 04/28/2022
• Supplement Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 102 KG