MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY NT BALANCE; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 511B

Device Problem Gas/Air Leak (2946)

Patient Problem Air Embolism (1697)

Event Date 04/19/2022

Event Type  Death  

Event Description

Medtronic received information that during use of an affinity nt oxygenator, it was reported that a gas leak occurred from the junction of the oxygenator and heat exchanger.After priming and circulating the cardiopulmonary bypass (cpb) circuit using an affinity nt oxygenator, as usual the perfusionist ensured that the circuit was air free.Just after 5 minutes of going on cpb for a cardiopulmonary bypass grafting (cabg) procedure, there was a sudden gush of massive air bubble produced from the oxygenator.Within no time the arterial line was full of air.The patient suffered a massive air embolism.Immediately cpb was stopped and the oxygenator was replaced.The customer again went on cpb with prior de-airing of the circuit with the second oxygenator.The customer tied to support the patient for a longer time but they could not revive the patient.It was stated that the cause of death was the massive air embo lism.Later the oxygenator was checked for its regular gas outlet using a 10l flow of gas into inlet.There was no exit of gas from its regular outlet.It was found that the gas was escaping elsewhere at the oxygenator heat exchanger junction when we immersed into a water.The customer stated that they found that the gas was escaping elsewhere at the oxygenator heat exchanger junction when they immersed it into water.The customer stated that there was no blood loss due to the leak.

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.

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.

Manufacturer Narrative

B5: medtronic received additional information that an arterial filter was not used.The entire procedure was done on pump electively.The medtronic nt oxygenator was replaced with the sorin device and the same circuit was used for the sorin device.Cpd spectra is a cardioplegia delivery system.It was included in the circuit after the event occurred and the affinity was removed from the circuit.In general, the customer doesn¿t use cardioplegia for cabg procedures.They had to use cardioplegia because the heart did not revert and also to finish the grafting procedure.The arterial pump used is a roller pump.Cardioplegia was being used during the case, blood cardioplegia and the blood taken from recirculation line of oxygenator.Air embolism occurred before the installation of cardioplegia.Device evaluation summary: visual inspection shows no outward signs of physical damage or abnormalities.Performed the water side pressure decay leak test on the water side.The test ramps up the pressure in the water side to 45 psig and then checks for a decay.During the test there were no leaks detected.Blood side pressure integrity testing was performed at 3 lpm with 23 psi, (1189 mmhg) of back pressure for 10 minutes.During the pressure integrity testing there were no leaks observed from the fiber bundle.Reason for return was not confirmed for any leaks.Conclusion: the device was returned to medtronic for analysis.Analysis of the returned device did not identify any device malfunction or evidence related to the cause or contribution of the device to the reported event.Review of the product's risks analysis found the related risk has been identified and assessed.The risk related to macro/micro-air (from hollow fiber) from entering blood phase details the use condition of a pressure differential across the fiber bundle can lead to gaseous macro/micro emboli (gme) to patient.As a micro porous membrane, the fiber bundle of the oxygenator requires oxygen and blood pressures to be maintained to ensure appropriate gas transfer.This risk is detailed in the instructions for use provided with the device.The dhr for the reported serial number of the device was reviewed and did not identify any anomalies or deviations in the manufacturing process which would cause or contribute to the reported event.Clinical review of this product event was done.Based on the information available including: return product analysis, video provided by customer, and procedure related details; there is no clear link established between the condition and performance of the device and the reported event.The reported patient harm of air embolism and death was determined to not be related to a malfunction of a medtronic device.The specific cause is unknown.Based upon this assessment, there is no known evidence that the device directly contributed to the patient death.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 NT BALANCE
• 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: 14719377
• MDR Text Key: 294232172
• Report Number: 2184009-2022-00139
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K191444
• 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,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2023
• Device Model Number: 511B
• Device Catalogue Number: 511B
• Device Lot Number: 223432276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2021
• 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
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 71 KG