MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY HFO W/TRILLIUM 511T; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 95215

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/30/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of an affinity nt oxygenator, that the oxygenator leaked when the patient¿s valve rep lacement was changed to cardiopulmonary bypass.Plasma protein was leaking from the oxygenator.Blood loss also occurred due to the leak.The specific amount of leaking fluid was asked but is unknown.A blood transfusion was required.The device was used to complete the procedure.There was no adverse patient effect reported.

Event Description

It was asked but is unknown whether the recirculation port used during priming/during the case.Large amounts of suction and venting were not used.There was no visible air in the system/tubing.No bubble detector was used.Because it was plasma protein leaking, it was impossible to calculate the specific blood milliliters lost.

Manufacturer Narrative

From investigation - complaint confirmed for leak.Sending additional supplemental report as some information was omitted in error in the report previously sent.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.

Manufacturer Narrative

Investigation - medtronic received information that during use of an affinity nt oxygenator, the oxygenator leaked when the patient¿s valve replacement was changed to cardiopulmonary bypass.Plasma protein leaked from the oxygenator.Blood was lost due to the leak and the specific amount of leaking fluid was unknown by the user.A blood transfusion was required.The device was used to complete the procedure.There was no adverse patient effect reported.Device was not returned for analysis so a cause cannot be determined but pictures were provided that confirm the report.The affinity nt oxygenator fiber/plasma leaks are an extremely low occurring phenomena with devices made with microporous membrane.The product is designed to maximize the performance and robustness of the oxygenator and medtronic uses extremely sophisticated techniques for identifying leaks in the production process.No serial number was provided but a lot number was provided and there are no known anomalies or deviations in this lot which would cause or contribute to the reported incident.This investigation was completed with the information that was provided, if additional information is received, this investigation will be reopened if deemed necessary.Trends for issues with this product are reviewed at quarterly quality meetings.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 HFO W/TRILLIUM 511T
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 11064026
• MDR Text Key: 223356115
• Report Number: 2184009-2020-00090
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K191029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 95215
• Device Catalogue Number: 95215
• Device Lot Number: 13353702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR