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

Model Number BB811

Device Problem Obstruction of Flow (2423)

Patient Problems Ischemia Stroke (4418); Thrombosis/Thrombus (4440)

Event Date 10/06/2023

Event Type  Death  

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.

Event Description

Medtronic received information that during use of a fusion oxygenator, it was reported that during extracorporeal circulation (cec), it was impossible to raise the patient's pressure, and there was a clot covering 80% of the surface of the membrane.The customer was unable to deliver to the arterial pump.It was reported that the membrane thrombosis caused the patient to have an ischemic stroke.It was reported that the patient died due to cerebrovascular attack (cva) three days later.Medtronic received additional information that the thrombus appeared almost instantly.The perfusionist wanted to obtain a flow rate on the pump of 5l/min, and the flow meter only showed 3l/min, with the patient's mean arterial pressure (map) remaining very low at around 20-30mmhg.Heparin plus act control was used as an intervention to manage thrombus formation.The temperatures of the arterial and venous lines of the oxygenator were blood temperature 35.5° celsius and venous temperature at 35° celsius.The customer stated that the fibrin developed suddenly.There was no use of vacuum assisted venous drainage (vavd) and no air entered the vein.An open circuit medtronic fusion was used.Heparin dosage was monitored using an act, which was 693 seconds at the start of the cec.There were no drugs used from the cec.It is unknown if the patient previously received heparin or another anticoagulant treatment.The cardiac output never exceeded 3l and there was no measurement of the venous flow.The customer stated that they carried out an occlusivity test in the morning.The customer stated that there was no blood sequestration in the pump, this was given after breast sampling.The level in the cvr was about 550ml.Medtronic received additional information that the patient was infused with isofundine throughout the anesthesia.The patient received anesthetic induction in intravenous anesthesia with objective of concentration (anesthésie intra-veineuse à objectif de concentration (aivoc)) with propofol and remifentanil after a bolus of ketamine and hypnovel; curarization was provided by nimbex.Antibiotic prophylaxis with cefazolin was administered.The customer stated that catecholaminergic support with noradrenaline was introduced, with a map target of 65-75mmhg.After establishing a baseline act of 118 seconds, a bolus of 21,000 iu of hnf (choay heparin) was injected into the central line, with a control act of 639 seconds prior to the start of bypass surgery.A 1.5g bolus of exacyl was injected after the heparin.The customer stated that concerning the cec circuit, the circuit was set up the day before surgery, debulking was performed in the morning with isofundine 1200ml and hnf 5000 iu.The surgeons checked that the cannulas were in the correct position and noted that there were no clots in the surgical field or cannulas.On the bypass side, there were no thrombi in the reservoir or elsewhere in the circuit, and only the membrane was affected by clots.A heparinemia and a blood count were taken and sent urgently to the laboratory.At the start of the procedure, the drugs used were indicated as pre-amputation.At the start of the cec, noradrenaline was increased because the map had dropped.When the perfusionist was alerted to a technical problem with the bypass machine, the patient continued to be ventilated and aortic clamping was not performed.After rapid medico-surgical consultation, it was decided to restore the volume of the bypass and stop it.Once the thrombosis on the oxygenator membrane had been identified, the department's heparin induced thrombocytopenia (hit) protocol was initiated after taking a heparinemia test (3.7ui/l) and an anti-pf4 ac test (negative).The protocol consisted of a bolus of cangrelor and unfractionated heparin (ufh), followed by cangrelor intravenous via infusion pump (intraveineuse seringue électrique (ivse)) before starting a second cec.The cell saver circuit was reassembled without heparin, and the arterial catheter bag was changed, without the addition of heparin.After the start of the second cec, the act was checked at 473 seconds.No incident occurred during this second cec; cangrelor was stopped during cec after the biologist called to confirm that there was no evidence of hit.The infusion records cannot be provided.The patient received heparin in (b)(6) 2023 during their coronary angiography.The customer indicated, they were tested for hit as an emergency measure at the time of the event, and then again at 48 hours, and the test was found to be negative.

Manufacturer Narrative

The ufh was injected at the end of the second breast retrieval.The time that elapsed corresponds to the time it took for the surgeon to complete the breast retrieval and cannulation before cec, which is approximately 40 minutes.The act at 639 seconds corresponds to the act performed a few minutes after injection of ufh.There was no other act prior to departure from the cef.Heparinemia was performed at the time of the incident (3.7), and an act was collected prior to the second cec (it was 473 seconds).At the start of the cec, the arterial filter was open, so very transiently there was a brief movement of recirculation which the customer stated is usual.It is unknown where the clot came from, and the customer stated that do not know why it happened.The cec was restarted with the same circuit.It is not physically possible to change the circuit in 1 min.The customer is concerned about the origin of the problem and considered a failure on a sensor that could have required a reboot.The patient did not receive protamine.The customer carried out a heparinemia test at the time of the incident, with a value of 3.7.The customer does not have an explanation for the thrombosis and believes there potentially is a problem inherent in the membrane.Pharmacovigilance was not carried out on the batch of heparin used.The customer could not confirm or deny if the thrombus could have caused patient stroke or death, no information could be provided on medical conditions and measures occurring at the time for the patient due to medical confidentiality.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

Device evaluation summary: visual inspection shows no outward signs of physical damage or abnormalities.Unit appears to have been used.Note: the customer provided photos showing evidence of clotting.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 and gas flows) the results are as follows: 146 mmhg blood side pressure drop reason for return was visually confirmed for clotting by the photos provided by the customer, however it was not confirmed for flow issues in the lab.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.

• 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: 18072371
• MDR Text Key: 327358460
• Report Number: 2184009-2023-01026
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00763000834210
• UDI-Public: 00763000834210
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• 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
• Device Lot Number: 227013983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2023
• 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; Death
• Patient Age: 58 YR
• Patient Sex: Male