MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY PIXIE PEDIATRIC HOLLOW FIBER OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	BBP211
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of an affinity pixie oxygenator, it was reported by a researcher that the oxygenators used in their research projects had mechanical failures when used within inline perfusion systems for pig liver and pig kidney.The flow rates were below 300 mmhg and between 30-60 minutes after beginning the process, the device would form a crack and cause outward leaking.The devices were replaced to complete the procedures.There were no adverse patient effects associated with this event.Medtronic received additional information that the customer is part of a research group working on pig and human liver perfusions.The breakage of all the devices were noticed within the same week of experiments, but the exact dates are not available.The customer stated that no blood was used but the solution used did leak significantly throughout the perfusion.The customer stated that the defect was not visible, only through the leakage.
Additional 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.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection showed evidence of an adhesive material around the ports of the device.Additional visual inspection showed evidence of damage, the recirculation port was broken off and there was a crack in the housing.During the cleaning process there was a leak from the crack.The reason for return was confirmed.Conclusion: the complaint was confirmed for the pixie oxygenator's crack and leak.The issue was verified during analysis of the returned device.Visual inspection showed evidence of adhesive material around the ports of the device, and evidence of damage including, a broken recirculation port and crack in housing.A leak was observed from the crack during the cleaning process.This type of damage would not be acceptable during manufacturing.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 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 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 PIXIE PEDIATRIC HOLLOW FIBER OXYGENATOR
• Common Device Name: 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: 16775174
• Report Number: 2184009-2023-00184
• Device Sequence Number: 20549988
• Product Code: DTZ
• UDI-Device Identifier: 20613994617310
• UDI-Public: 20613994617310
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K183511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

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
• Operator of Device: Other
• Device Model Number: BBP211
• Device Catalogue Number: BBP211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown