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

Model Number CB811

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/14/2023

Event Type  Injury  

Manufacturer Narrative

Device evaluation: visual inspection showed that the temperature monitoring adapter (tma) was loose, and it could be easily removed.Additional visual inspection showed evidence of adhesive.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 tma.The reason for return was confirmed.Conclusion: complaint confirmed for the fusion oxygenator's loose and leaking 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 non-conforming material reports (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 via fa1302, which provides device use recommendations for affected product.Root cause investigation 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.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.

Event Description

Medtronic received information that during use of a fusion oxygenator, it was reported the patient had a failed transcatheter mitral valve implant and their condition was unstable and declining, so an emergency prime and crash bypass was performed.The customer was not sure if there was a leak during priming that was missed due to emergency of the situation but noted it was a very slow leak at about 1 drop every 5 seconds.It is not believed that the patient contributed to incident.The device was used to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that there was a blood leak of 0.2 mls/ 5 sec on average.That is 2.4ml/min over 208 minutes which is about 500mls of blood loss, and the patient was transfused with two units of blood.The leak was noticed after bypass commenced, within 10 minutes of commencing bypass.The leak continued until the patient was weaned from bypass.There were multiple reasons for the need of a transfusion, which include but may not be limited to: low blood volume/ pressure, and blood loss from surgery.Medtronic received additional information that the temperature monitoring adapter (tma) detached with finger light torque, it was not over torqued, this was not a test.The temperature probe atp210 was removed as per the recommendation with a twist and slide off, no extra torque was applied atthe time.This event took place after verbal discussion of fa 1302 to not over torque and avoid manipulation during the case, but before field education on the issue.The leak occurred during bypass, nothing was noticed from the packaging, nor during set-up/prime.The detachment of the tma occurred at circuit takedown at operation end.Medtronic received additional information that the customer reiterated that the tma was not manipulated in the case from the time of temperature probe attachment to the detachment.All temperature probes are inspected regularly and are cleaned.There was no change to the practice of attaching the temperature probe during the setup of the device.The customer recalls no extra torque being applied and there was no resistance or any different feel to the application of the temperature probe and nothing to disconcert them regarding attachment at the time of application.The customer said management of the clinical situation was the higher priority but recalls nothing unusual about the temperature probe attachment.During the procedure, the surgeon and theatre team were advised of the blood leak.The patient's condition and the leak problem were assessed, and decision was made at that point of the operation to swap out the oxygenator.The customer attempted to wean the patient from bypass to perform the swap procedure, but the patient was too unstable to safely perform the swap.A clinical decisionwas made by the customer to proceed with the surgery using the device, monitoring the blood leak and blood loss.They then recommenced cardiopulmonary bypass (cpb) at full flow.The leak was manageable, whilst the patient was warm and hemodynamically extremely unstable.

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.

• Brand Name: FUSION HFO CARMEDA COATED
• 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: 16538357
• MDR Text Key: 311238112
• Report Number: 2184009-2023-00118
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00643169785731
• UDI-Public: 00643169785731
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CB811
• Device Catalogue Number: CB811
• Device Lot Number: 225205444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1025-2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention