MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY NT CVR NON STERILE; RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Model Number 61399409468

Device Problem Obstruction of Flow (2423)

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

Event Date 09/18/2020

Event Type  malfunction  

Event Description

Medtronic received information that during use of the affinity nt cardiotomy venous reservoir (cvr) the reservoir screen did not allow blood to flow properly through the cvr.The cvr was used to complete the case.There were no adverse patient effects as a result of the issue.Three cvr batches were used in the manufacture a custom pack.Additional information from the sales rep: the issue was that the blood was sequestered behind the screen and wasn't passing through to the reservoir.They were off bypass when this happened but there was concern that the blood would not be able to pass over the screen if they had to go back on bypass.

Manufacturer Narrative

Device evaluation summary: visual inspection shows no outward signs of any damage/assembly errors.During the cleaning process there was flow observed through the screen.Reason for return was not confirmed.Conclusion: reported event was not confirmed.A cvr was returned and visual inspection shows no outward signs of any damage/assembly errors.Analysis concluded device performed as expected and was unable to confirm the reported event.The dhr for the reported serial number of the device was reviewed and did not identify any anomalies or deviations in the manufacturing process which would cause or contribute to the reported event.Although the specific root cause cannot be determined, since the reported event could not be duplicated and no discrepancies were found with the device the cause is most likely related to use conditions.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 CVR NON STERILE
• Type of Device: RESERVOIR, BLOOD, 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: 17126957
• MDR Text Key: 317170106
• Report Number: 2184009-2023-00529
• Device Sequence Number: 1
• Product Code: DTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K936003
• 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: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 61399409468
• Device Catalogue Number: 61399409468
• Device Lot Number: 13337624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2020
• 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