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

Model Number BB811

Device Problems Gas Output Problem (1266); Obstruction of Flow (2423)

Patient Problems Low Blood Pressure/ Hypotension (1914); Shock (2072)

Event Date 10/16/2023

Event Type  Injury  

Event Description

Medtronic received information that during use of a fusion oxygenator, it was reported that during a cardiac surgery (pulmonary valve replacement) procedure that required crc, thrombosis occurred on the device.A heparin bolus was given and the act control was correct at 405 seconds (requires 400 seconds to start circulation extra-corporelle (cec)), there was a progressive increase in flow rate and attainment of theoretical flow rate within two minutes.There was significant difficulties ventilating the patient and a need for excessive increase in fio2 as there was very dark blood appearing to be non-oxygenated in the cardio-tome, there were trace amounts of thrombotic fibers in the oxygenator.The fio2 was increased to the maximum, and the patient's blood was darkened and did not seem to be oxygenated.The patient experienced low blood pressure with large hypoperfusion (mean arterial pressure (map) was 35-40) despite doses of supratherapeutic amines which rapidly increased resistances (clamped pump head at 4000 rpm) with arterial flow loss impossible to compensate with the centrifugal pump being at max 4000 rpm. the customer stated that there was a lot of thrombus in the oxygenator.After alerting the entire surgical and anaesthetic team, checking the correct functionality of the circuit and the correct position of the cannula on the surgical field a decision was made to change the circuit.There was no additional adverse patient effect associated with this event.Medtronic received additional information that ringer lactate and isofundine and 2000ui heparin were used in the circuit before starting the procedure.Exacyl (5ml) was given after starting the procedure.The temperatures of the arterial and venous lines of the oxygenator were 35°-36° celsius.It was stated that the clots appeared suddenly during the first 5 minutes after starting the procedure.The customer stated that there was no fibrin.No sucker was used.A hms plus was used to monitor heparin dosing and the act was 480 seconds.The patient had only been on heparin before starting the procedure, the patient had not been on any other anti-coagulant therapy.The venous and cardi flow rates were 4.5 ¿ 5 l/min.The pump was an ap40 centrifugal pump.The level in the cvr was 2 l.Pericardic blood was sent to the cell saver, but it was not returned to the patient.The customer stated that crc refers to cec extra corporeal therapy.Medtronic received additional information that the patients low blood pressure resolved after the circuit was replaced.

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

Device evaluation summary: visual inspection shows evidence of a clot/fibrin.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.Testing was conducted at a 1:1 ratio (7lpm blood <(>&<)> gas flows) the results as reported below: ¿ 288 ml/min 02 xferc ¿ 160 ml/min co2 xferc ¿ 286 mm/hg delta pblood reason for return was undetermined.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

Correction d4.3 (expiration date): this field has been updated.Correction h4 (device mfg date):this field has been updated.Correction h6.4 (eval code result (fdr/annex c)): this code has been updated.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: 18117817
• MDR Text Key: 327865037
• Report Number: 2184009-2023-01039
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K203111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2023
• 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