MAUDE Adverse Event Report: PERFUSION SYSTEMS FUSION HFO CARMEDA COATED; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	CB811
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: visual inspection showed that the temperature monitoring adapter (tma) is loose and can be easily removed.Additional visual inspection showed evidence of adhesive.The reason for return was confirmed for the tma being loose.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 or Problem Description
Medtronic received information that during use of a fusion oxygenator, it was reported that the circuit was used without incident and they came off bypass with the temperature probe removed from fusion temperature monitoring adapter (tma).There was a need to go back into bypass and when the probe was reattached, bleeding occurred from the port.Once the temperature probe was secured, the bleeding stopped.The device was used to complete the case.There was no additional adverse patient effect associated with this event.The customer stated that about 10 mls of blood was lost.Medtronic received additional information that the tma port did not noticeably detach in the incident.The perfusionist reported that when they went to put the temperature probe in again when going back to bypass, blood spurted out of the port into their hand but stopped when the probe was placed in the tma.There was no transfusion required as a result of the leak.There was no damage to the packaging.There was no damage to the device.
Additional Manufacturer Narrative
Conclusion complaint confirmed for the fusion oxygenator's loose temperature monitoring adapter (tma).The issue was verified via analysis of the returned device.Review of this unit¿s device history record found no abnormalities or ncmrs initiated during manufacturing that would cause or contribute to the reported event.This unit passed all required testing and inspections during manufacturing.Customer communication of this issue has been initiated, which provides device use recommendations for affected product.Root cause concluded the presence of ebs (ethylene bis stearamide) wax on the new tma component affected the material properties that caused the torque specification to not be met.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: FUSION HFO CARMEDA COATED
• 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: 16634193
• Report Number: 2184009-2023-00142
• Device Sequence Number: 17671550
• Product Code: DTZ
• UDI-Device Identifier: 00643169785731
• UDI-Public: 00643169785731
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K203111
• 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
• Remedial Action: Notification,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2023

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: 09/19/2024
• Device Model Number: CB811
• Device Catalogue Number: CB811
• Device Lot Number: 225107679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1025-2023
• Patient Sequence Number: 1
• Patient Sex: Male