MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 7FM HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 03735

Device Problem Increase in Pressure (1491)

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

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.The inspire 7f hollow fiber oxygenator is a non-sterile device assembled into a sterile convenience pack (item in01551 - (b)(6), lot 2102020084) 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 7f hollow fiber oxygenator is a non-sterile component assembled into a convenience pack that is not distributed in the usa.The standalone oxygenator (catalog number 050729 - inspire 7f m) is registered in the usa (510(k) number: k200683).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 7f hollow fiber oxygenator.The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformity relevant to the reported issue.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, during a procedure, the pre-membrane pressure of the inspire 7f oxygenator increased over 500 mmhg.Medical team elected to change out the heart lung machine and the circuit.Patient was administered with platelets, plasma and allogenic blood.There is no report of any patient injury.Based on follow up information with customer, in the first phase of surgery there was no increase in the pressure drop through the oxygenator.Since patient's aorta started to bleed after surgery, perfusionist returned on bypass and resumed hlm and the circuit where protamine was previously administered at the end of surgery (act time measured at this point was 496 seconds).The pre-membrane oxygenator pressure reached 600 mmhg approximately 20 minutes after returning on cpb.Medical team elected to change out the entire hlm and circuit.The change out took 18 minutes and the procedure was completed without any further issue.Patient was then given blood transfusion and coagulation sustaining factors the patient was not harmed.

Event Description

See intial report.

Manufacturer Narrative

Livanova received report of transmembrane pressure increase relevant to an inspire 7f oxygenator approximately 20 minutes after returning on cpb (cpb was initially completed and patient was administered of protamine).The entire circuit was replaced and procedure completed with no issue.Patient was administered of heterologous blood and coagulation sustaining factors.There is no report of any patient injury.The involved oxygenator was returned to livanova for investigation.Visual inspection found clotted blood in the integrated arterial filter.The oxygenator was washed and dried prior to testing.The oxygenator was tested as per design specifications and the transmembrane pressure increase was reproduced.Analysis of perfusion data included within provided pump-sheet of the case, revealing a pressure excursion above the expectations during surgery verification of manufacturing records confirmed that claimed device was released as conform according to specifications.Analysis of complaints database revealed no other similar event notified for batch concerned out of (b)(4) total manufactured units, this excluding a possible quality manufacturing issue.Taking into account that system worked properly for the entire duration of cpb and that transmembrane pressure increase was observed only after returning on by-pass after protamine administration to the circuit, livanova believes there is no direct relationship between claimed event and any manufacturing defect of involved device was established.Based on investigation results and collected information, most likely root cause of occurred event was assigned to undesired cellular activation inside the circuit associated with platelet adhesion and fibrin layer deposition within the oxygenator, due to specific characteristics of the blood.It is reasonable to assume that blood remaining inside circuit after first phase of surgery was no longer anticoagulated (under protamine's effect) and hence prone to get clotted following a long period of stagnation.No device malfunction was confirmed, no specific action was currently deemed necessary.Livanova maintains monitoring the market for similar events.

• Brand Name: INSPIRE 7FM HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 12251413
• MDR Text Key: 266467113
• Report Number: 9680841-2021-00019
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2024
• Device Catalogue Number: 03735
• Device Lot Number: 2101260144
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1