MAUDE Adverse Event Report: PERFUSION SYSTEMS CARMEDA AFFINITY NT HOLLOW FIBER OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number CB511

Device Problem Air/Gas in Device (4062)

Patient Problem Cardiac Arrest (1762)

Event Date 03/08/2021

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use, the customer reported air bubbles in the custom pack's fusion oxygenator during ecmo.Use of the device was discontinued due to the patient's condition.The patient subsequently died.The reported device issue was thought by the customer to be associated with the patient's death.Additional information: the customer thought the yellow air bubbles were plasma serum, that event was recorded through the gas out at the period time 14hr, 30hr, 36hr respectively since the system was working.The recirculation port was used during priming/during the case.Large amounts of suction and venting were not used.There was no visible air in the system/tubing.A bubble detector was not used.The purge line was run open, attached to the port in the cardiotomy inlets.

Event Description

Medtronic received information that during use, the customer reported air bubbles in the custom pack's fusion oxygenator during ecmo.Use of the device was discontinued due to the patient's condition.The patient subsequently died.Additional information: the customer thought the yellow air bubbles were plasma serum, that event was recorded through the gas out at the period time 14hr, 30hr, 36hr respectively since the system was working.The recirculation port was used during priming/during the case.Large amounts of suction and venting were not used.There was no visible air in the system/tubing.A bubble detector was not used.The purge line was run open, attached to the port in the cardiotomy inlets.Additional information from the sales rep: the fusion oxygenator was not alleged by the customer to be related to the patient¿s death.They expected that the oxygenator could run up to 72 hours and they would be able to observe the patient over that time.However, after 36-hours running on ecmo, the incident occurred.At that time, the customer assessed a poor patient prognosis, so they decided to stop ecmo.

Manufacturer Narrative

Please see the following updates since filing the initial mdr: b.2.¿date of death: g.2.¿pma / 510(k) #: device was confirmed to be a cb511 (affinity nt oxygenator) medtronic's investigation is ongoing.An update will be provided in a supplemental mdr.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.

Manufacturer Narrative

Medtronic investigation and conclusion product was not returned but the customer provided a photograph which shows clear evidence of plasma break through (type of fiber leak).Duration of use, air temperatures, blood temperatures, and other factors can cause condensation within the micro-pores.This phenomenon can lead to plasma breakthrough/fiber leak.The product is designed to maximize the performance and robustness of the oxygenator for all use conditions and medtronic uses extremely sophisticated techniques for identifying and minimizing the potential for leaks throughout product design and production.Affinity nt oxygenator plasma breakthrough/fiber leaks are an extremely low occurring phenomena with devices made with microporous membrane.No serial number was provided, and no product was returned to determine the serial number.A pack lot number was provided which was made using two lots of oxygenators (lot numbers: 13323646 & 13319757).The dhr for the reported lot numbers were reviewed and did not identify any anomalies or deviations in the manufacturing process which would cause or contribute to the reported event.The ifu for the affinity nt hfo states the following warnings: the benefits of extracorporeal support must be weighed against the risk of systemic anticoagulation and must be assessed by the prescribing physician.A replacement oxygenator should be readily available during perfusion.The affinity nt oxygenator is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (cpb) procedures up to 6 hours in duration.Under this guidance, the fda is allowing temporary limited modifications to the indications of certain fda-cleared or fda-approved cardiopulmonary devices without prior submission of premarket notification.These modifications are allowed, in light of the public health emergency, when they do not create an undue risk.This indication modification is in effect for the duration of the public health emergency related to covid-19, as declared by the department of health and human services (hhs).In accordance with the fda guidance, the device has a modified indication for use during the covid-19 public health emergency.This indication modification has not been cleared or approved by the fda, but shall apply temporarily to the device models listed in this supplement: the device can be used for longer than 6 hours in an extracorporeal membrane oxygenation (ecmo) circuit to treat patients who are experiencing acute respiratory or acute cardiopulmonary failure.Medtronic cannot confirm or deny if the length of the procedure contributed to the reported incident.A specific root cause cannot be determined but the most likely cause is use condition related.A clinical review of product event (b)(4) was completed with medtronic's office of medical affairs and quality management.The assessment reviewed available information, both from the customer and from the products risk management file.Based upon this assessment, there are no new risks associated with the use of this device as no new failure modes or use conditions of the system have been observed.No capa, documentation updates, or other actions are deemed necessary.This complaint investigation was completed with the information that was provided, if additional information is received, this investigation will be reopened if deemed necessary.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.

Event Description

Medtronic received information that during use, the customer reported air bubbles in the custom pack's fusion oxygenator during ecmo.Use of the device was discontinued due to the patient's condition.The patient subsequently died.Additional information: the customer thought the yellow air bubbles were plasma serum, that event was recorded through the gas out at the period time 14hr, 30hr, 36hr respectively since the system was working.The recirculation port was used during priming/during the case.Large amounts of suction and venting were not used.There was no visible air in the system/tubing.A bubble detector was not used.The purge line was run open, attached to the port in the cardiotomy inlets.Additional information from the sales rep: the fusion oxygenator was not alleged by the customer to be related to the patient¿s death.They expected that the oxygenator could run up to 72 hours and they would be able to observe the patient over that time.However, after 36-hours running on ecmo, the incident occurred.At that time, the customer assessed a poor patient prognosis, so they decided to stop ecmo.

• Brand Name: CARMEDA AFFINITY NT HOLLOW FIBER OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 11705734
• MDR Text Key: 246664944
• Report Number: 2184009-2021-00022
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K191029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CB511
• Device Catalogue Number: CB511
• Device Lot Number: 219450648
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Weight: 60