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

Model Number CB811

Device Problems Fluid/Blood Leak (1250); Gas Output Problem (1266)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2023

Event Type  malfunction  

Event Description

Medtronic received information that during use of a carmeda fusion hollow fiber oxygenator, it was reported that during surgery with ecc, the device worked poorly.Co2 was delivered to the open chest, and the oxygen delivery was good.But then the carbon dioxide ventilation began to deteriorate significantly from the normal speed of 3-4 liters of fresh gas flow.13 liters are required to keep pco2 below 6kpa.The device could only deliver 10 liters, so an extra fresh gas hose was spliced onto the existing one, and 3 liters was then supplied from the anesthesia machine's rotameter.Anesthetic gas also leaked from the oxygenator, and this forced customer to change the anesthesia strategy to propofol infusion.The device was used to complete the procedure.There was no adverse patient effect associated with this event.

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 received additional information that the anesthetic gas leak was most prominent at the base of the oxygenator.The customer reported a smell.There was no physical damage noted on the device.The device was used 45 minutes prior to the event.There was 1200ml of ringer-acetate, 10.000e of heparin and 200ml of aprotinin used during priming.There were no clots present.There was low gas exchange observed.There was an inspection of the gas outlet for condensation.There was no occlusion of condensation.The waste anesthetic gas was controlled and in function.The gas flow was 13 liters which should have removed any possible condensation.The patient's hematocrit at the start of bypass was 29,9.The patient's hematocrit at the start of the event was 21,9.The heparin dosing was monitored to achieve optimal therapeutic response by measuring the act values with an i-stat.The act value at initiation was greater than 1000 seconds and was never below 546 seconds during ecc.The patient was not previously on heparin or another anti-coagulant therapy.There was 1,400ml of prime solution in the circuit prior to initiation.The patient was given 4 units of donor blood during ecc.The donor blood, whole or components did not reside in the circuit prior to the initiation.The patient was septic and had infectious endocarditis and was in a deteriorate state.The set used was drawing m460331k.There are no perfusion records for the event due to patient integrity laws.Medtronic received additional information that the patient was given the 4 units of donor blood to maintain a hematocrit above the customers set threshold of 24.The 4 units of blood were not given as a result of the gas leak.The procedure was started with liquid sevoflurane vaporized in a non-medtronic gas vaporizer.The anesthetic gas is mixed with the fresh gas flow of oxygen/air and delivered into the gas inlet of the oxygenator.The flowrate of co2 to the field was initially set to 5 liters/min which is standard practice and a flowrate that in a normal case would render in a fresh gas flow of 3-4 liters/min.There was one sucker and one vent used during the procedure.The sucker was initially set at a flowrate of approximately 0,8 liters per minute and temporarily adjusted to current need of clearing the field from bloodshed.The vent vas set at approximately 0,4 liters/min.When the problem with co2 remo val became an issue that became more and more severe, the co2 delivery to the field was reduced to 3 liters per minute and the sucker was also reduced to approximately 0,5 liters/min but still increased temporarily at requests of the surgeon.The speed of the vent was not adjusted.Gas scavenging was performed with the extra gas flow with anesthetic gas.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 received additional information that the patients sepsis was related to pre-procedure condition.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: 18215055
• MDR Text Key: 329075297
• Report Number: 2184009-2023-01064
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00763000225476
• UDI-Public: 00763000225476
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K230640
• 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: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CB811
• Device Catalogue Number: CB811
• Device Lot Number: 226801351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2023
• Date Device Manufactured: 07/01/2023
• 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 Age: 55 YR
• Patient Sex: Female
• Patient Weight: 80 KG