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

Model Number BB811

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/31/2022

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 prior to use of a fusion oxygenator, it was reported that priming fluid leaked from the purge line of the artificial lung.The customer observed that the custom tubing pack circuit used at the same time was dirty.The customer stated that since the issue was observed during priming, all circuits and centrifugal pumps were replaced to complete the procedure and additional time was used in preparation but did not affect the start of surgery.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that the leak was only at the purge line of oxygenator.No foreign matter has been identified, the material on the custom tubing pack circuit was priming solution.The fusion oxygenator and cardiotomy venous reservoir (cvr) which were used were not part of the custom tubing pack.Medtronic received additional information that the leaking line was coming out of the oxygenator and was connected to the cvr.

Manufacturer Narrative

Product analysis: visual inspection showed evidence of damage/hole in the air purge line.The device appeared to have been primed.Pressure integrity testing was performed at 3 l/pm with 23 psi, (1189 mmhg) of back pressure for 10 minutes.During the pressure integrity testing there was a leak observed from the damaged area.The reason for return was confirmed.Conclusion: the complaint was confirmed for the torn and leaking fusion oxygenator purge line.The issue was identified during analysis of the returned device which showed evidence of damage/hole in the air purge line, and pressure integrity testing resulted in a leak from the tear.This type of damage would not be acceptable during manufacturing.Review of this devices¿ device history record found no abnormalities or non-conforming material reports initiated during manufacturing that would cause or contribute to the reported event.This device passed all testing and inspections during manufacturing.The root cause is unknown, but potentially related to damage occurring during shipping or storage.There were no patient/clinical safety issues reported.Trends for issues with this device are reviewed at quarterly quality meetings.Correction section d 4.4 lot number: this field 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.

• 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: 15310355
• MDR Text Key: 305268036
• Report Number: 2184009-2022-00234
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K183490
• 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
• Report Date: 10/20/2022

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 Model Number: BB811
• Device Catalogue Number: BB811
• Device Lot Number: 224087129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2022
• Initial Date FDA Received: 08/29/2022
• Supplement Dates Manufacturer Received: 09/22/2022
• Supplement Dates FDA Received: 10/20/2022
• 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