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

Model Number CB811

Device Problem Increase in Pressure (1491)

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

Event Date 10/08/2021

Event Type  Injury  

Manufacturer Narrative

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, the customer reported that greatly elevated pressure occurred in the circuit (pre-oxygenator pressure) rapidly after about 5-7 min of the cpb.After checking the arterial cannula and circuit, an additional pressure was applied to the circuit (post-oxygenator pressure), which confirmed that a high pressure drop in the oxygenator has occurred.The problem was isolated to the oxygenator.Treatment with nitroprusside was started as treatment for the high blood pressure according to routine, but the high pressure drop persisted.Then was decided that the oxygenator needed to be replaced.Ecc was terminated, the oxygenator was changed as usual.During the oxygenator exchange, the patient had their own adequate circulation, and before exchange the cpb was stopped.Directly after the exchange, the cpb was started again.Ecc was started immediately after the change-out. there was no patient impact associated with this event.Additional information: for about 10-15 minutes, the perfusion from the heart-lung machine could not deliver full flow.Throughout the process, the patient had their own supporting circulation.The prime volume was 1400ml of ringer-acetat with 10 000iu/heparin.Standard anesthesia drugs were used during the case.And nitroprusside when the pressure drop occurred.Initial pre oxygenator pressure was measured, and after the increased pressure, post oxygenator was also measured.The heparin dosing calculation was 400iu/kg, and act is aimed to 480sec.After bolus dose (45 000iu) the act was 494.After 5 min cpb it was 580 sec.Before oxygenator exchange another 10000iu was given, and after exchange the act was 1000sec.The temperatures pre and post oxygenator were as follows: pre oxy temp 34.8c.Post oxy temp 34.1c.

Manufacturer Narrative

Product analysis: visual inspection showed evidence of clotting and fibrin.The device was cleaned using a renalin solution.Pressure integrity testing showed no internal or external leaks when run at 3 lpm with 23 psi, (1189 mmhg) of back pressure for 10 minutes.The device was sent to the blood lab for performance testing.Testing was conducted at a 1:1 ratio (7lpm blood gas flows) the results are as follows: 199 mmhg blood side pressure drop.The reason for return was not confirmed.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

Conclusion: the complaint was not confirmed for the fusion oxygenator's high pressure.Analysis of the returned device was unable to replicate the reported incident.The returned oxygenator resulted in a blood side pressure drop of 199 mmhg at a flow rate of 7 l/min.This is used as an indicator for device performance from a restricted flow or high pressure drop perspective, and the results were as expected.Analysis of the returned product confirmed the presence of clotting in the fiber bundle.The device history record was reviewed; devices are required to pass manufacturing inspections and specifications prior to release and no abnormalities were documented which would cause or contribute to the reported occurrence.Testing suggests the high-pressure excursion experienced may be patient or clinically related.Other potential contributing factors include low heparin protocols, temperature extremes, or variability in heparin potency causing a faster decline in anti-coagulation than anticipated.Trends for issues with this device are monitored.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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12770425
• MDR Text Key: 280458446
• Report Number: 2184009-2021-00108
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K183490
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 01/04/2023
• Device Model Number: CB811
• Device Catalogue Number: CB811
• Device Lot Number: 221398139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2021
• 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): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 108 KG