MAUDE Adverse Event Report: PERFUSION SYSTEMS FUSION HOLLOW FIBER OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BB811

Device Problem Increase in Pressure (1491)

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

Event Date 05/10/2021

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 the affinity fusion oxygenator high pre-membrane pressures were observed.Fifteen minutes into bypass and whilst cooling to 32 degrees the perfusionist noticed pre-membrane pressures of 380mmhg climbing to 500mmhg.The target patient blood flow was 5.6lpm (relatively large patient).The pressure isolators and equipment were checked.As pressures were continuing to rise a second opinion was sought and the decision was taken to change out the oxygenator.At that stage (20 minutes into bypass) the customer was on maximum revolutions per minute on their centrifugal pump (3500rpm) and could only maintain a flow to the patient of 3.5lpm approximately.Blood gas was performed and the patients parameters were still okay.The patient was not yet cross clamped and cardioplegia had not been given yet.The anaesthetist ventilated the patient whilst the perfusionist changed out the oxygenator (approximately 5 minutes to change out the oxygenator, done in a controlled manner as the patient was stable).Upon initiating bypass with a new (second) oxygenator, the perfusionist also noticed high pre-membrane oxygenator pressures.The hi gh pressure alarm was set off at 550mmhg.The perfusionist managed to maintain a flow of approximately 5.2lpm and the blood gas results of the patient were acceptable.The second period of bypass was around 2 hours long.As the patient was being rewarmed towards the end of the bypass the pre-membrane pressure did start falling to normal levels (330mmhg pre and 210mmhg post membrane).During both bypass periods the customer stated the acts were good (>480 on medtronic act plus).The customer also used a hms hepcon heparin management system.This patient had a target heparin concentration of 3mg/kg.Despite acts being good the hms results stated to provide more heparin (anticoagulate the patient more).During the bypass an additional 20000 units of heparin were given.The patient's hemoglobin was 120g/liter, but the perfusionist did try and run at slightly lower of 150g/liter.There were no known patient blood anomalies prior to bypass.The patient was given aprotinin and also aprotinin at the end of bypass (prescribed - as had passed the allergy check).Customer could not rule out "patient conditions" for the event, especially as the same phenomena was occurring on the replacement oxygenator.Note: this initial mdr relates to the first oxygenator (sn (b)(4)) used in the case.A separate mdr will be submitted for the second oxygenator (sn (b)(4)) used in the case.

Manufacturer Narrative

Device evaluation summary: visual inspection shows no outward signs of physical damage or abnormalities.Unit appears to have been used.Pressure integrity testing shows 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.Reason for return was not confirmed.Conclusion: complaint not confirmed for the fusion oxygenator's high pressure.Analysis of the returned device was unable to replicate the reported incident.The customer reported a pressure of 500 mmhg, however, analysis of the returned oxygenator resulted in a blood side pressure drop of 182 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 within the functional requirements.Medtronic testing suggests the high-pressure excursion experienced is 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.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.There were no patient/clinical safety issues reported.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.

• Brand Name: FUSION HOLLOW FIBER OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 11861899
• MDR Text Key: 264946950
• Report Number: 2184009-2021-00042
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K183490
• 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: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2022
• Device Model Number: BB811
• Device Catalogue Number: BB811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention