MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY NT OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 95212

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/12/2022

Event Type  malfunction  

Event Description

Medtronic received information that during use of an affinity nt oxygenator, the customer reported leak after extracorporeal circulation transferred the machine.The device was replaced to complete the procedure.There was no patient impact associated with this event.Additional info states that no fluid leakage found during prime, blood leakage during use.No damage to device, packaging or the contents within the package.10ml of blood was lost due to leak, but a transfusion was not required.

Manufacturer Narrative

Conclusion: reported event was not confirmed.Medtronic received information that during use of an affinity nt oxygenator, the customer reported leak after extracorporeal circulation transferred the machine.Product was not returned for analysis and is not expected from the customer; therefore, event could not be confirmed.A picture was provided which showed a used oxygenator but did not show a location or source of a leak.Insufficient information is available to determine specific leak location, use conditions, or other details so the cause of the event cannot be determined.The device was not returned and no valid serial number was provided so a dhr review was not possible.Trends for issues with this product are reviewed at quarterly quality meetings.This regulatory report is being submitted as part of a retrospective review and remediation per d00953163 as part of a capa action.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AFFINITY NT OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17127393
• MDR Text Key: 317867368
• Report Number: 2184009-2023-00534
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K191029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 95212
• Device Catalogue Number: 95212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2022
• Initial Date FDA Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: No
• 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