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

Catalog Number 050715J

Device Problem Increase in Pressure (1491)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2022

Event Type  malfunction  

Manufacturer Narrative

Patient information were not provided.The expiration date refers to the sterile finished product.The complained inspire 6f oxygenator (catalog number 050715j, lot 2107060095) is not distributed in the usa, therefore the udi is not applicable.The oxygenator item 050715j is similar to the inspire 6f oxygenator 050715, which is distributed in the usa, for which the device identifier is (b)(4).The product item 050715j is not distributed in the usa and it is similar to the inspire 6f oxygenator 050715, which is distributed in the usa (510(k) number: k120185).The device manufacture date refers to manufacture date of the sterile, finished oxygenator.Sorin group (b)(4) manufactures the inspire 6f oxygenator.The incident occurred in (b)(6).During follow up with the customer it was clarified that increase of the pressure drop up to 340mmhg across inspire oxygenator 6f soon after the beginning of the surgery, which required medical team to change-out the unit with a new one.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.

Event Description

Sorin group (b)(4) has received a report that, at the begin of a procedure using an inspire 6f oxygenator, the transmembrane pressure increased.Medical team elected to change-out the oxygenator with a competitor oxygenator and completed the case.There is no report of any patient injury.

Event Description

See initial report.

Manufacturer Narrative

Livanova received a report of increased pressure drop up across inspire oxygenator.Medical team elected to change-out the unit.Through follow-up communication, livanova learned that change-out of the unit was conducted during by-pass and lasted about 10 minutes.No harm to the patient as well as no pre-existing coagulation disorder were reported.Review of the livanova complaints database did not identify any other similar event relevant to the batch concerned of oxygenator.Verification of manufacturing records confirmed that involved part was released as conform according to specifications.The complained oxygenator was received at livanova for investigation.After decontamination by gamma-rays (as per livanova procedure on blood contaminated goods), returned unit clean.Biological residues were detected only inside integrated arterial filter module.The oxygenator was functionally tested as per design specifications.Laboratory test could not reproduce any increased pressure drop across the oxygenator.Based on investigation results and review of similar events, the increased hydraulic resistance to passage of blood reported by customer was reasonably assigned to undesired cellular activation and build up of biological material inside circuit as a result of 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.No device malfunction could be reproduced or confirmed.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
• Type of Device: 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: 14165986
• MDR Text Key: 290454937
• Report Number: 9680841-2022-00023
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 050715J
• Device Lot Number: 2107060095
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/24/2022
• Initial Date FDA Received: 04/21/2022
• Supplement Dates Manufacturer Received: 10/18/2022
• Supplement Dates FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1