MAUDE Adverse Event Report: SORIN GROUP ITALIA DIDECO EOS ECMO M PHISIO; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 050521

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.The expiration date refers to the sterile finished product.The complained eos ecmo oxygenator (catalog number 050521, lot 2009110064) is not distributed in the usa, therefore the udi is not applicable.The oxygenator item 050521 is similar to the item 050576 - eos pmp, eos pmp integrated oxygenator, which is distributed in the usa, for which the device identifier is (b)(4).The product item 050521 - eos ecmo oxygenator is not distributed in the usa, but it is similar to the item 050576 - eos pmp, eos pmp integrated oxygenator, which is distributed in the usa (510(k) number: k150489).The device manufacture date refers to manufacture date of the sterile, finished oxygenator.Sorin group (b)(4) manufactures the item 050521 - eos ecmo oxygenator.The incident occurred in (b)(6).The involved device has been requested for return to sorin group (b)(4) for investigation.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 an ecmo procedure with covid patient, blood was idenfied in the tubing to a maquet heater-cooler.There is no report of any patient injury.

Manufacturer Narrative

Livanova received a report regarding a blood leak from the hansen connectors of the water compartment of an eos ecmo oxygenator.The oxygenator was replaced.There is no report of any patient injury.Customer reported that priming phase was performed according to ifu.The issue was confirmed from explanatory photo provided by customer revealing the presence of blood in the tubes from oxygenator to maquet hypo.The oxygenator was received a livanova facility for investigation.Initial visual inspection did not identify any obvious damage or non-conformity.To investigate the claimed issue, the blood compartment of the oxygenator was filled with water and pressurized.The leak test could not reproduce the leak from the hansen connector from water in the blood compartment at 1400mbar for at least 10 minutes.This could be caused by the condition in which the unit was returned: the unit was returned full of blood and clots.Despite the device has been extensively washed before the test, it is possible that blood clots have blocked the hole in the metal sheet thus preventing the leakage.To further investigate the issue, the oxygenator was autopsied, and the metal sheet was sectioned to identify the point where the sheet was damaged.The hole was not identified.A possible explanation is that the damage was in the potting area.For technical reasons, during the autopsy, the potting area is damaged and cannot be saved during its removal from the metal sheet and thus cannot be investigated.Dhr of the complained eos ecmo did not identify any issue.All (100%) of the units are leak tested during manufacturing: the complained oxygenator has successfully passed the leak test.Review of the livanova complaint database did not identify any other similar event relevant to the lot of oxygenator or heat exchanger module thus excluding any systematic issue.To investigate the possible root causes of communication between water and blood compartments, the (b)(4) was opened.Results of the investigation suggested the most probable root causes are residual processing stress associated to cold metal sheet deformation combined by corrosion, presence of sand residue after sanding process and degradation of compacting surface.Despite the risk is acceptable and the frequency of this type of event is low (incredible), to further decrease the occurrence, livanova has planned to start to treat metal sheet of eos ecmo&pmp oxygenators with primer to improve the corrosion resistance.The validation activities have been completed and implementation of this action is planned by end 2021.Livanova investigation could not reproduce the claimed leakage.However, the issue was confirmed from explanatory photo provided by customer revealing the presence of blood in the tubes from oxygenator to maquet hypo.Based on the above, it cannot be ruled out that most probable root cause is a manufacturing damage that is not detectable during manufacturing test.The damage evolves after device release with the contribution of some other factors such as corrosion, residual sand and degradation.Livanova has identified action to improve the corrosion resistance of the metal sheet.As no specific root cause was identified and the probability is acceptable, no other action was deemed necessary.Livanova will maintain monitoring the market for similar events.

• Brand Name: DIDECO EOS ECMO M PHISIO
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; 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: 11820308
• MDR Text Key: 265360872
• Report Number: 9680841-2021-00012
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2023
• Device Model Number: 050521
• Device Lot Number: 2009110064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2022
• 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