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

Model Number BB811

Device Problem Gas Output Problem (1266)

Patient Problems Stroke/CVA (1770); Low Cardiac Output (2501)

Event Date 09/21/2020

Event Type  Injury  

Manufacturer Narrative

Lot #: there are two possible lot numbers for the fusion oxygenator - lot #'s 13321059; 13321367.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, it was noticed that the oxygenator was not oxygenating.Prior to the event the plan was to replace the mechanical aortic valve prosthesis.The patient had endocarditis, was embolized and presented in a cerebrovascular event that is unknown if it was ischemic or hemorrhagic in origin.There was no ct prior to the procedure.The procedure had two pump times.The first 180 minutes and the second 50 minutes with a second oxygenator.At 120 min after the start the pump, the patient presented vasoplegia, index 3, for which the perfusionist administered methylene blue.The perfusionist noticed that the oxygenator was not oxygenating well so it was decided to change the oxygenator when the second pump time was about to start.When the oxygenator was changed the patient's metabolism was corrected.The flow was 3 lit / min during the procedure.It was reported that the patient is alive with injury, the patient remains in icu, intubated and awaiting further tests.The patient woke up slowly and tac (cat) shows hemorrhagic focus.The extended procedure time was not a result of the event, it was inherent to the patient's state.

Event Description

Medtronic received information that during use of a fusion oxygenator, it was noticed that the oxygenator was not oxygenating.Prior to the event the plan was to replace the mechanical aortic valve prosthesis.The patient had endocarditis, was embolized and presented in a cerebrovascular event that is unknown if it was of ischemic or hemorrhagic in origin.There was no ct prior to the procedure.The procedure had two pump times.The first 180 minutes and the second 50 minutes with a second oxygenator.At 120 min after the start the pump, the patient presented vasoplegia, index 3, for which the perfusionist administered methylene blue.The perfusionist noticed that the oxygenator was not oxygenating well so it was decided to change the oxygenator when the second pump time was about to start.When the oxygenator was changed the patient's metabolism was corrected.The flow was 3 lit / min during the procedure.It was reported that the patient is alive with injury, the patient remains in iuc, intubated and awaiting further tests.The patient woke up slowly and tac (cat) shows hemorrhagic focus.The extended procedure time was not a result of the event, it was inherent to the patient's state.

Manufacturer Narrative

Correction: previous information that was submitted in section h10 of report number 2184009-2020-00067, follow-up 001 contained a ty pographical error.The submitted information stated incorrectly that there were no patient/clinical safety issues reported.This has been corrected in the record and the patient information was outlined in report number 2184009-2020-00067.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 investigation and conclusion: complaint is not confirmed for poor gas transfer as the returned device functioned as intended.Complaint confirmed for fibrin/clotting as the visual inspection showed evidence of blood staining (protein build-up) through-out the fiber bundle.Flow was established while cleaning the device and during testing, indicating that the device itself did not have blockages.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.This investigation was completed with the information that was provided, if additional information is received, this investigation will be reopened if deemed necessary.Trends for issues with this product are reviewed at quarterly quality meetings.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.

Event Description

Medtronic received information that during use of a fusion oxygenator, it was noticed that the oxygenator was not oxygenating.Prior to the event the plan was to replace the mechanical aortic valve prosthesis.The patient had endocarditis, was embolized and presented in a cerebrovascular event that is unknown if it was of ischemic or hemorrhagic in origin.There was no ct prior to the procedure.The procedure had two pump times.The first 180 minutes and the second 50 minutes with a second oxygenator.At 120 min after the start the pump, the patient presented vasoplegia, index 3, for which the perfusionist administered methylene blue.The perfusionistnoticed that the oxygenator was not oxygenating well so it was decided to change the oxygenator when the second pump time was about to start.When the oxygenator was changed the patient's metabolism was corrected.The flow was 3 lit / min during the procedure.Itwas reported that the patient is alive with injury, the patient remains in iuc, intubated and awaiting further tests.The patient woke up slowly and tac (cat) shows hemorrhagic focus.The extended procedure time was not a result of the event, it was inherent to the patient's state.

• 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: 10669201
• MDR Text Key: 211238154
• Report Number: 2184009-2020-00067
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BB811
• Device Catalogue Number: BB811
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Date Manufacturer Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 75