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

Model Number BB811

Device Problem Obstruction of Flow (2423)

Patient Problem Stroke/CVA (1770)

Event Date 01/20/2024

Event Type  Death  

Event Description

Medtronic received information that during use of a fusion oxygenator, the customer reported that there was a thrombosis incident.The procedure was an aortic dissection.Use of the oxygenator was continued.The patient has expired.Medtronic received additional information that the patient's cause of death was encephalic death due to multiple ischemic strokes.The customer stated that the oxygenator did not fail in its ability to oxygenate the patient correctly but it was responsible for the multiple strokes seen in the patient.The customer stated that the performance problem caused or contributed to the death as it resulted in the embolic strokes.The customer stated that the thrombotic process was visualized on the only observable face of the oxygenator, in the space after the immediate oxygenator fibers.As the planned operation was performed under normothermic conditions, only the arterial line temperature was monitored.The lowest temperature was 34.4°c.The customer stated that they do not know whether the thrombotic process developed slowly or suddenly.It was noted approximately 50 minutes after starting the bypass.A problem with the oxygenator was suspected because the fio2 requirement of the membrane ventilation gases was considered abnormally high (75%).Air did not enter the venous reservoir as a result of particular " related to table manners ".During the procedure, the vacuum assisted venous drainage (vavd) was used for a short period of time, less than 15 minutes and with a vacuum of 10 to 15 mmhg.Anticoagu lation was monitored by hms plus.The target act on trasylol is 480 seconds.Continuous blood gas monitoring per bypass was performed by cdi.See the attached perfusion records.The patient had not previously received heparin or any other anti-coagulant treatment.The pump configuration was a roller pump.The customer stated that this was a "classic" bypass with an arterial roller pump and venous return in an "open" cardiotome (cvr).Blood recovered by the cell saver was processed and reintroduced into the venous reservoir at the end of the procedure, shortly before the circulation extra-corporelle (cec) was stopped and well after the thrombotic process was observed in the oxygenator.The customer stated that the venous drainage was easy, with no vavd for most of the time during bypass, and with a level of more than 800 ml most of the time.The following medicines were used as first-line treatment and during the case; for anaesthesia and resuscitation: propofol, sufentanil, ketamine, tracrium, lidocaine, ephedrine, noradrenaline, insulin, for antibiotic prophylaxis: cefazoline, for reducing the risk of bleeding: antifibrinolytic: trasylol and for anticoagulation: heparine (panpharma).The customer provided the following record of act values and doses of heparin reinjections: 22h15 act 498 sec.+ 20 mg heparin 22h45 act 503 sec.+ 20 mg heparin 22h51 start cec 23h06 act 331 sec.+ 60 mg heparin 23h24 act 558 sec.23h55 act 513 sec.00h25 act 493 sec.+ 20 mg heparin 00h50 act 388 sec.+ 50 mg heparin 01h15 act 461 sec.+ 40 mg heparin 01h50 act 533 sec.02h15 act 446 sec.+ 50 mg heparin 02h40 act 459 sec.+ 60 mg heparin 03h05 act 618 sec.03h30 cec stopped 03h33 act 558 sec.

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 showed evidence of blood.Pressure integrity testing showed 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: ¿ 400 ml/min 02 xferc ¿ 257 ml/min co2 xferc ¿ 174 mm/hg delta pblood the reason for return was visually confirmed for clotting by the photos provided by the customer, however it is undetermined for gas transfer in the lab.Conclusion: the complaint was confirmed for fibrin/clotting as the visual inspection showed evidence of blood staining (protein build up) in some areas of the fiber bundle.Analysis of the returned device was unable to replicate the reported incident.Flow was established while cleaning the device, indicating that the device itself did not have blockages; the device primed with no issues and the circuit operated from 0 to 7 lpm with approximately 176 mmhg back pressure with no flow issues.This is used as an indicator for device performance from a restricted flow or high pressure drop perspective, and the results were as expected.Additional visual inspection shows no outward signs of any damage or assembly errors.This would suggest a clinical or patient related issue because it appears the clotting cascade was activated resulting in thrombus formation in the fiber bundle.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.Medtronic will continue to monitor for future trends and occurrences.Correction b2 (outcome attributed to adverse event): the intervention required checkbox has been selected.Correction additional codes (imf (annex f) health impact): this code has been updated.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 18621019
• MDR Text Key: 334256818
• Report Number: 2184009-2024-00049
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00763000834210
• UDI-Public: 00763000834210
• Combination Product (y/n): N
• Reporter Country Code: RE
• PMA/PMN Number: K230640
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• 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: 227013980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2023
• 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): Death; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 97 KG