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

Model Number 541B

Device Problem Obstruction of Flow (2423)

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

Event Date 04/27/2021

Event Type  malfunction  

Event Description

Medtronic received information that during use of the affinity nt cardiotomy venous reservoir (cvr) the customer observed blood held up in the rear cardiotomy portion of the cvr that would not come through the screen into the front venous reservoir outlet section of the cvr.The use of the cvr was continued.There were no adverse patient effects as a result of this issue.

Manufacturer Narrative

Device evaluation summary: the results of the analysis determined there were no manufacturing errors or damaged components specific to the venous section of the device that would cause or contribute to the hold-up reported in the venous screen.Reason for return was undetermined.Conclusion: complaint not confirmed.Due to the return condition and the fact that the report was most likely use related, it was not reasonable to do performance testing.Blood left in the device after use can clot and cause performance issues that do not represent the device in actual use condition.A review the dhr found no anomalies and most of the blood lab testing was as expected, this suggests the device was physically manufactured appropriately.The device has been designed and tested to ensure the cvr has appropriate flow and filtration properties.The exact cause is unknown but there is a potential that blood coagulation occurred in the cvr.Although it may have been momentary, this could affect the device even if the majority of the case maintained an acceptable anticoagulation protocol.The ifu for the affinity nt cvr states the following; a strict anticoagulation protocol should be followed, and anticoagulation should be routinely monitored during all procedures.The benefits of extracorporeal support must be weighed aga inst the risk of systemic anticoagulation and must be assessed by the prescribing physician.Adequate heparinization must be maintained before and during bypass.The event could also be related to poor blood handling techniques that lead to increase blood trauma/ hemolysis.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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
• 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: 16807682
• MDR Text Key: 313930429
• Report Number: 2184009-2023-00198
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 541B
• Device Catalogue Number: 541B
• Device Lot Number: 13338991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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