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

Catalog Number 050713

Device Problem Pressure Problem (3012)

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

Event Date 12/06/2021

Event Type  malfunction  

Event Description

Sorin group italia has received a report po2 of 49mmhg on fio2 of 100% after 10 min for cpb start.Oxygenator replaced to solve the issue.There is not report of any patient injury.

Manufacturer Narrative

Patient id, age, gender, weight and ethnicity: patient information were not provided.Sorin group italia manufactures the inspire 6 hollow fiber oxygenator with integrated and hardshell.The incident occurred in (b)(6).The involved device has not been requested for return to sorin group italia for investigation.Through follow-up livanova learned that the event occurred before cross clamp.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

Verification of manufacturing records confirmed that involved unit was released as conform according to specifications.Review of complaints database revealed no other similar events notified for batch concerned out of (b)(4) total manufactured units, excluding any possible quality defect manufacturing-related.This poor gas exchange condition was identified during a beating-heart surgical phase, prior to applying the aortic cross-clamp.Medical team elected to change out the oxygenator and cpb was initiated and completed without further problems.Based on all the above facts, livanova believes the most likely root cause of reported failure was a multifactorial issue, resulting from the interaction between clinical procedure, patient conditions and initial gas-blood settings.However, presence of shunted area across oxygenating hollow fibers cannot be excluded and/or undesired cellular activation associated with platelet adhesion and fibrin layer deposition inside the oxygenator, biological deposits may coat the fiber bundle capillaries in which the blood flows thus hindering the passage of o2.The above-described contributing factors might have reduced the area to perform gas exchange and a concomitant increase of gas pathway length to perform gas exchange.As no device malfunction could be confirmed, no action is deemed necessary.Livanova will keep monitoring the market.

• Brand Name: INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR
• 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: 13167396
• MDR Text Key: 286677315
• Report Number: 9680841-2022-00001
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K130209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 050713
• Device Lot Number: 2106160058
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/16/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1