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

Catalog Number 050713J

Device Problem Increase in Pressure (1491)

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

Event Date 01/27/2022

Event Type  malfunction  

Event Description

Sorin group (b)(4) has received a report that, during a procedure, the transmembrane pressure of the inspire 6 oxygenator increased up to 500mmhg.Medical team elected to change out the oxygenator.There is no report of any patient injury.

Manufacturer Narrative

Patient information were not provided.The expiration date refers to the sterile finished product.The complained inspire 6 oxygenator (catalog number 050713j, lot 2105240078) is not distributed in the usa, therefore the udi is not applicable.The oxygenator item 050713j is similar to the inspire 6 oxygenator 050713, which is distributed in the usa, for which the device identifier is (b)(4).The product item 050713j is not distributed in the usa and it is similar to the inspire 6 oxygenator catalogue 050713, which is distributed in the usa (510(k) number: k130209).The device manufacture date refers to manufacture date of the sterile, finished oxygenator.Sorin group (b)(4) manufactures the inspire 6 hollow fiber 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.

Manufacturer Narrative

Livanova received a report about high inlet pressure during surgery.The oxygenator was replaced with another one during hearth beating phase of surgery and change out took 5-10 minutes.Patient/user not affected.Analysis of the provided pump sheet confirmed the increased transmembrane pressure after 24 minutes of usage.The involved oxygenator was returned to livanova for testing.Visual inspection found clotted blood in the returned oxygenator.The oxygenator was extensively washed and dried before laboratory testing.Functional test with bovine blood confirmed the increased transmembrane pressure.Verification of manufacturing records confirmed that claimed device was released as conform according to specifications.Analysis of livanova complaints database revealed no other similar event relevant to the complained lot, thus excluding a possible quality manufacturing issue.Based on investigation results and collected information, most likely root cause of occurred event was assigned to the increase of hydraulic resistance due to undesired cellular activation inside the circuit associated with platelet adhesion and fibrin layer deposition within the oxygenator.This type of event is a multi-factorial phenomenon possibly triggered by a combination of clinical procedure, therapies (e.G.Anticoagulant prescription, heparin composition and priming composition) and patient-specific health conditions.In addition, laboratory test could be also related to the conditions of returned clogged device which presented biological deposits which reasonably reduced the open surface for blood flow, this resulting in increased pressure drop through the unit.The risk is in the acceptable region.No corrective action is deemed necessary.

Event Description

See initial report.

• Brand Name: INSPIRE 6 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: 13597892
• MDR Text Key: 286430756
• Report Number: 9680841-2022-00011
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/14/2022

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 Expiration Date: 05/22/2024
• Device Catalogue Number: 050713J
• Device Lot Number: 2105240078
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/25/2022
• Supplement Dates Manufacturer Received: 05/19/2022
• Supplement Dates FDA Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2021
• 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