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

Model Number BB811

Device Problem Increase in Pressure (1491)

Patient Problems Cardiovascular Insufficiency (4445); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2022

Event Type  Injury  

Event Description

Medtronic received information that during use of a fusion oxygenator, it was reported that perfusion was started and immediately after cardiopulmonary bypass (cpb) started, a high pressure dropped occurred over the membrane in the oxygenator.Delta p was greater than 400 mmhg, and it was not possible to run full flow.The oxygenator was replaced to complete the procedure. after weaning off bypass and priming a new heart and lung machine (hlm) the patient was not in a good condition.There were two lots of fusion oxygenator used in the manufacture of this custom tubing pack: 225129311 and 225129310.Medtronic received additional information that within the first 10 minutes of the procedure, the pressure raised to over 400 mmhg.The device was primed with the usual ringer lactate 1450 ml and 15000 ie heparin.Pre-oxygenator pressure measured was over 600 mmhg, and the customer had to adjust the limit to over 550 mmhg on the hlm to not stop the machine.Post-oxygenator pressure was around 200mmhg.An act was used to monitor heparin dosing.There was 50000ie heparin given before the hlm was started and the the act was 461 seconds.After that, an additional 10000 ie heparin was given to the patient, and there was 15000ie heparin in the hlm.The temperatures pre and post oxygenator were normothermic 37 degrees celsius, 36.5 degrees celsius post op and a venous temperature of 36 degrees celsius measured approximately, within 0.5-1 degrees.It was reported that the patient was transferred to their own hospital, and there seems to be no consequences from the episode.The patient was given noradrenaline in connection with the episode, as the customer from the beginning started cooling, and gave extra fluid, 1.5 liter of ringer lactate.Heparin bolus of 25000 ie, and at the same time reducing the flow, as did have an effect on the mean arterial pressure.Before shift of the hlm the act was >1000 sec.Despite this, the customer experienced a new raise of the delta p to 170 mmhg on a new heart lung machine, after a period of time the delta p dropped to 85-90 s on 5.3 liter flow.

Manufacturer Narrative

There were two lots of fusion oxygenator used in the manufacture of this custom tubing pack, so there are two possible lot numbers for the device: 225129311 and 225129310.The exact serial/lot number of the oxygenator was not provided.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.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

Correction h6: patient codes (ime/annex e) updated, as it was previously reported that the patient was transferred to their own hospital, and there seemed to be no consequences from the episode.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
• 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: 16136589
• MDR Text Key: 307064623
• Report Number: 2184009-2023-00029
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K203111
• 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
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BB811
• Device Catalogue Number: BB811
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 01/11/2023
• Supplement Dates Manufacturer Received: 03/01/2023
• Supplement Dates FDA Received: 03/28/2023
• 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 Outcome(s): Required Intervention
• Patient Weight: 125 KG