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 01/26/2024

Event Type  Injury  

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, the customer reported that shortly after starting the procedure, the customer noticed that the device was thrombosing.The device was replaced to complete the procedure.Medtronic received additional information that the patient suffered multiple strokes with right hemiplegia, impaired alertness, prolonged ventilation and delayed extubation.The following medicines were used during the case; xylo, dexamethasone, ketamine, sufenta, diprivan, tracrium, tranexamic acid, cefazoline, loxen, noradrenaline and heparin.The temperatures of the arterial line and the venous line of the oxygenator were 36.5 and 37°.Standard operation, return of 3 aspirations in the venous cvr, there was no excessive use of lv suctions or vents, etc.The presence of thrombus was observed 10 minutes after bypass.A hms was used to monitor heparin dosage.The value before starting bypass was 441.Per cec 408/613/673/538/437.The patient received a standard loading dose of heparin before starting cec with correct hms control.The venous and cardiac flow outputs per bypass were between 3.9 and 4.1 l/mn.The pump configuration was a roller pump.The aspirated blood was not sequestered in the cell saver before being reintroduced into the venous reservoir (cvr).The level in the cvr venous reservoir was 300ml.The perfusion records could not be provided as there is no computer recording of cec data within the establishment.Medtronic received additional information that customer records po2 and pco2 values during bypass surgery and there was no abnormalities, the customer has stated that they do not have these records.The customer stated that they have not analysed the atiii values.The customer stated that the dosage of exacyl is adapted to weight.Bolus 15mg/kg then 10mg/kg/h.The customer stated that they assess the initial fibrinogen value of patients perioperative value 4.5g/dl.

Manufacturer Narrative

Device evaluation summary: visual inspection shows evidence of fibrin.The customer provided photos showing evidence of thrombus.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 (7 lpm blood and gas flows) the results as reported below: 348 ml/min 02 xferc, 219 ml/min co2 xferc,176 mm/hg delta pblood reason for return was visually confirmed for thrombus by the photos provided by the customer, however it was not confirmed in the lab for pressure drop issues.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: 18750313
• MDR Text Key: 335893159
• Report Number: 2184009-2024-00092
• Device Sequence Number: 1
• Product Code: DTZ
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• 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): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 65 KG