MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 8 HOLLOW FIBER OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 03703

Device Problem Increase in Pressure (1491)

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

Event Date 10/15/2021

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided the inspire 8 m start hollow fiber oxygenator is a non-sterile device assembled into a sterile convenience pack (item in00647, lot 2011090095) that is not distributed in the usa.The expiration date refers to the sterile finished product into which the oxygenator was assembled.As the sterile convenience pack is not distributed in usa, the udi number is not applicable.The complained inspire 8 start oxygenator is not distributed in the usa.The oxygenator inspire 8 start is similar to the oxygenator inspire 8 m (catalogue 050701), which is distributed in the usa, for which the device identifier is 08033178112260.Lot of the complained inspire 8 start oxygenator could not be identified.Possible lots are 2011030001 or 2011030001 or 2010160105 or 2010230.The complained inspire 8 start oxygenator is a non-sterile component assembled into a convenience pack that is not distributed in the usa.The stand alone inspire 8 start oxygenator is not distributed in the usa and is similar to the inspire 8 oxygenator (catalogue 050701) that is registered in the usa (510(k) number: k180448).The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the oxygenator was assembled.Sorin group (b)(4) manufactures the inspire 8 start m hollow fiber oxygenator.The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The involved device is not available for return to sorin group (b)(4) for investigation.Follow up with the customer clarified the following points: no oxygenation performance issue was reported.Blood flow rate pre-membrane was 5 lpm, post-membrane was 0.5 lpm the pump sheet of the procedure is not available the low pressure occurred at the starting surgery, after clamping and before declamping medical team elected to change out the oxygenator blood loss occurred during oxygenator change out.Prolonged procedure caused increased assistance in post declamping 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 of oxygenator low pressure during procedure.Surgery was prolonged of 30 minutes.There is not report of any patient injury.

Manufacturer Narrative

Verification of manufacturing records confirmed that noticed device was released as conform according to specifications.Analysis of complaints database revealed no other similar cases notified for batch concerned.Part was not made available for return, nor pump-sheet was provided to support the investigation.Based on information provided during follow up with the customer, livanova believes the most probable root cause of the reported hydraulic resistance to passage of blood exhibited by oxygenator was traced back to increase of the pressure drop across the unit, most likely due to undesired cellular activation 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.The risk is in the acceptable region.No specific action is currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See initial report.

• Brand Name: INSPIRE 8 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: 12802621
• MDR Text Key: 283483343
• Report Number: 9680841-2021-00031
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: TS
• 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: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2023
• Device Catalogue Number: 03703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/24/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/09/2020
• 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
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 75 KG