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

Model Number	BBP211
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of a pixie oxygenator, it was reported that a leak occurred.The device was replaced, but the rest of the custom tubing pack was used to complete the procedure.There was no patient impact associated with this event.Medtronic received additional information that event occurred at the beginning of the procedure, while on bypass, but before x-clamp.The amount of patient blood loss as a result of this leak was between 5 to 10ml.A transfusion was not required as a result of this leak.There was no damage to the device, the packaging or other contents within the package.There was no air in the system/tubing and no adverse patient effects.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection showed no outward signs of physical damage or abnormalities.The device appeared to have been used.Photos provided by the customer showed evidence of a blood leak through the antistatic shunt.Pressure integrity testing was performed at 1 lpm with 23 psi, (1189 mmhg) of back pressure for 10 minutes.During the pressure integrity testing there were no leaks observed from the device.The reason for return was visually confirmed; however, it was not replicated in the lab.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
Conclusion: the complaint was confirmed for the pixie oxygenator's leak from the top of the device.The issue was verified via the customer-provided photos; however, the issue was not replicated during pressure integrity testing of the returned device.The customer-provided photos appear to show a blood leak near the antistatic shunt.The pixie oxygenator is 100% leak tested during production, and devices that exhibit leaks are discarded prior to distribution.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.The root cause is undetermined.Trends for issues with this product are reviewed at quarterly quality meetings.Correction b5: there was no adverse patient effect associated with this event.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: 15938213
• Report Number: 2184009-2022-00404
• Device Sequence Number: 20443653
• Product Code: DTZ
• UDI-Device Identifier: 20613994617310
• UDI-Public: 20613994617310
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2023

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: Health Professional
• Device Expiration Date: 09/29/2023
• Device Model Number: BBP211
• Device Catalogue Number: BBP211
• Device Lot Number: 223928490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2022
• 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 Age: 9 MO
• Patient Sex: Female
• Patient Weight: 9 KG