MAUDE Adverse Event Report: PERFUSION SYSTEMS FUSION HOLLOW FIBER OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BB811

Device Problems Fluid/Blood Leak (1250); Air/Gas in Device (4062)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2023

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

Medtronic received information that during use of a fusion oxygenator, the customer reported that the device was leaking and foaming.The use of the device was unspecified.There was no adverse patient effect associated with this event.

Manufacturer Narrative

Conclusion: the complaint was confirmed for the fusion oxygenator's foam and leak from the bottom of the device.The device did not return for analysis; however, the issue was verified via the customer-provided pictures and videos, which appeared to show foam and a leak from the bottom of the device.Fiber bundle leaks occasionally occur in oxygenators made with microporous membrane due to the variability in the fiber.Although these leaks do occur, the fusion oxygenator is 100% leak tested during production, and devices that exhibit leaks are discarded prior to distribution.It is possible pressure from adjacent fiber wraps lead to the acceptable results during leak testing, but the fiber relaxed during further processing, resulting in the leak.Review of this unit¿s device history record found no abnormalities or non-conforming material reports (ncmrs) initiated during manufacturing that would cause or contribute to the reported event.This unit passed all leak testing and inspections during manufacturing.Trends for issues with this pr oduct are reviewed at quarterly quality meetings.Additional review of the event showed that this leak was a fiber leak.Based on complaint history and risk analysis, the chance of a fiber leak resulting in a death or serious injury if this product event were to recur, in this device or a similar device, is remote.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.Correction h6 (patient codes/ime/annex e): this code has been updated.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

Additional information b.5: the device was used to complete the procedure.Medtronic received additional information that the input was not changed.There was no visible damage to the device, the packaging or other contents within the package.There were no large amounts of suction and venting used, it was in normal range.There was no visible air in the system/tubing.There was no bubble detector.The purge line was run closed.There is no data for patient blood loss.There was no transfusion required.The recirculation port was used during priming.Medtronic received additional information that the input was not changed.There was no visible damage to the device, the packaging or other contents within the package.There were no large amounts of suction and venting used, it was in normal range.There was no visible air in the system/tubing.There was no bubble detector.The purge line was run closed.There is no data for patient blood loss.There was no transfusion required.The recirculation port was used during priming.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: FUSION HOLLOW FIBER 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: 17180287
• MDR Text Key: 318027879
• Report Number: 2184009-2023-00591
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00643169178168
• UDI-Public: 00643169178168
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K203111
• 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,Followup,Followup
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: BB811
• Device Catalogue Number: BB811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male