MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

Catalog Number 050716

Device Problem Medical Gas Supply Problem (2985)

Patient Problem Ischemia (1942)

Event Date 06/22/2021

Event Type  malfunction  

Manufacturer Narrative

Lot of the oxygenator has not been provided.Therefore, expiry date and udi are unknown.Lot of the oxygenator has not been provided.Therefore, manufacturing date is unknown.Sorin group (b)(4) manufactures the inspire 8f m hollow fiber oxygenator.The incident occurred in (b)(6).On (b)(6) 2021, follow up information with the customer clarified the following points: the minimum po2 value reached during cpb was 55 mmhg.At the time of this measurement, blood flow was about 4.2 lpm and fio2 was ranging from 60 to 80%.To improve gas exchange performance, tubing connections between gas-blender and oxygenator were changed, gas flow rate was raised to 8 lpm and fio2 to 100%.First blood-gas report taken after referred maneuvers revealed increased blood oxygenation levels since a po2 value of 494 mmhg.However, medical team elected to change-out involved oxygenator and took 3 minutes to carry out the replacement.Blood-gas flow settings were returned to baseline values (4,2-4,3 lpm blood flow, fio2 60-70%) and a po2 value of 317 was achieved.Surgery was completed with po2 values steadily kept above 280 mmhg.There was no impact on oxygenator performance in removing co2 from patient blood.Patient outcome: immediate post-surgery attempts to wake and extubate, failed.Dense left hemiplegia, right lower limb weakness ¿ eventually required tracheostomy.Slow respiratory wean, as a result.Continuing itu level care.On 24/06/2021, there are differential diagnoses of patient status: no evidence of bleeding.Rt hemisphere: low density changes with ischemic features in the occipital lobe (area pca), and others too.Low perfusion, substrate of ica stenoses.Mild microvascular changes.According to customer, central oxygen supply and all connections and circuits were checked.Tube, including filter, connecting blender and oxygenator changed at 11.58h.Ventilation with a tidal volume of 200ml and 8lit flow (fio2=100%) was started at 11.58h 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 poor oxygenation during a procedure.No information of patient injury was reported.

Manufacturer Narrative

Based on additional information provided, the minimum po2 value reached during cpb was 55 mmhg.At the time of this measurement, blood flow was about 4.2 lpm and fio2 was 60-80%.To improve gas exchange performance, tubing connections between gas-blender and oxygenator were changed, gas flow rate was raised to 8 lpm and fio2 to 100%.Meanwhile, also ventilation with a tidal volume of 200ml was o started.First blood-gas report taken after referred maneuvers revealed increased blood oxygenation levels since a po2 value of 494 mmhg.Medical team elected to change-out the inspire oxygenator and replacement was completed in 3 minutes.After change-out, the blood-gas flow settings were returned to baseline values (4,2-4,3 lpm blood flow, fio2 60-70%) and a po2 value of 317 mmhg was measured.Surgery was completed without any further issue.The complained inspire oxygenator was returned to livanova for investigation.Prior to any functional testing, the oxygenator was gamma-ray decontaminated as per livanova procedure on blood contaminated goods.Functional test performed using bovine blood could not reproduce the reported poor oxygenation: the oxygenator behaved as expected.In details, performance test was done by simulating the procedure conditions (blood flow rate of 4.2 lpm, gas flow rate of 4.2 lpm and fio2 70%).During laboratory tests in the above provided conditions, the po2 value measured in arterial line was constantly above 175 mmhg, this providing a 100% of hemoglobin oxygen saturation.No decay in gas exchange performance levels was reproduced and no device product malfunction could be confirmed.Dhr verification did not identify any issue.No other similar complaint was received relevant to the oxygenator lot thus excluding any systematic issue.Based on lab testing results, no oxygenator malfunction could be confirmed.This is coherent with the observation that, when the blood-flow:gas-flow was increased from 1:1 to 1:2 together with the increase of the fio2 (from 60% to 100%), the blood oxygenation has increased to 494 mmhg.Considering that medical team replaced also the tubing and filter from the gas blender to the oxygenator, we can speculate that a possible root cause might be investigated in this connection.Since no device malfunction could be confirmed, the risk is in the acceptable region and no corrective action is deemed necessary.Livanova will keep monitoring the market.

Event Description

See initial report.

• Brand Name: INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
• Type of Device: OXYGENATOR
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola, modena
• 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: 12206270
• MDR Text Key: 266415366
• Report Number: 9680841-2021-00018
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K180448
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2023
• Device Catalogue Number: 050716
• Device Lot Number: 2011200157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2020
• 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 Sex: Male
• Patient Weight: 68 KG