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

Model Number BB811

Device Problems Increase in Pressure (1491); Obstruction of Flow (2423)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 10/05/2023

Event Type  Injury  

Manufacturer Narrative

Device evaluation summary: visual inspection shows evidence of clotting/fibrin.Pressure integrity testing shows no internal or exte rnal 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, per tr4164.Testing was conducted at a 1:1 ratio (7lpm blood & gas flows) the results are as follows: 230 mmhg blood side pressure drop.Reason for return was confirmed for clotting/thrombus and undetermined for pressure drop.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 there was heparin bolus administered before starting.The act was at 478 seconds, therefore, the customer started the extracorporeal therapy.The flow increased to the optimized flow, after 2 minutes, the customer reported high pressure and the flow decreased.The act tested at 200 seconds, therefore, loosing efficacity in 2 minutes.The customer reported that there was a thrombus in the device.The device was replaced.The patient experienced hypotension.Medtronic received additional information that pressure increased suddenly, and there was no pressure measurement.The temperatures of the arterial and venous line are unknown.The location of fibrin/thrombus/clots were on the oxygenator fibers.The fibrin grew suddenly (réinjection 10 000 ui d'héparine).There was no air in the line, no aspiration intracardiac, and the perfusion record was deleted when the customer changed the circuit.The patient was previously on apixaban, the venous and cardi flow rates were 4,5 l/min, and a centrifuge configuration was used.The sucker blood was not sequestered to the cell saver before returning to the cardiotomy venous reservoir (cvr).The level in the cardiotomy venous reservoir was 500ml.Medtronic received additional information that no drugs were used in prime or during the case.The temperatures pre and post oxygenator were 35°c.The hypotension was due to the thrombus resulting in decreased arterial flow.Noradrenaline was required to manage the hypotension experienced by the patient.

• 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: 18290104
• MDR Text Key: 329997313
• Report Number: 2184009-2023-01070
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: BB811
• Device Catalogue Number: BB811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/08/2023
• 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