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

Model Number BB811

Device Problems Fluid/Blood Leak (1250); Gas Output Problem (1266)

Patient Problem Coagulation Disorder (1779)

Event Date 07/09/2023

Event Type  Death  

Manufacturer Narrative

Device evaluation summary: visual inspection shows evidence of a fiber leak with blood staining on the top and bottom of the fiber bundle.Pressure integrity testing was performed at 3 l/pm with 23 psi, (1189 mmhg) of back pressure for 10 minutes.During the pressure integrity testing there was a leak observed from the top and bottom of the fiber bundle.Note: the customer provided video and photos showing evidence of fibers leaking.Reason for return was confirmed for leaking.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 the customer had an emergent thoracoabdominal aneurysm repair.Around the 5th hour on pump the oxygenator started showing evidence of failure.It was reported that the oxygenator was struggling to maintain po2 and pco2 despite 100% fio2 and 10 l/min of sweep, blood tinged foam out of bottom of oxygenator, ruptured membranes on the top and bottom.It was reported that the total pump time was 6 hours and 25 minutes.The oxygenator began showing signs of failure about the 5 hour mark on pump.The patient was rewarmed at a point where the customer just focused on stabilizing the patient to come off bypass, so they avoided an oxygenator changeout on pump.The patient did pass away after coming off pump but it was reported that this was due to severe coagulopathy and ventricular failure, not necessarily due to failure to oxygenate.It was also reported that the customer gave a significant amount of blood and plasma on pump, not any cryo or platelets and the activated clotting time (act) was adequate the entire time.The device was used to complete the procedure.There was patient death.Medtronic received additional information that there was no known damage to the device or packaging.Average arterial flows were about 4.8-5.3 l/min throughout most of the case, average arterial line pressure was low 200s.There was no evidence of air in the tubing and no suspected air embolus.Oxygenator failure was suspected when the customer noticed the arterial pco2 was climbing on the arterial cdi monitor, despite no other hemodynamic or pump changes.The sweep was already at 6 l/min when the cdi was reading a pco2 of 65, the customer turned up sweep to 8 l/min and checked a blood gas to confirm and the arterial cdi reading was correct, then turned the sweep to the max setting of 10l/min and that's when the customer noticed the bloody foam and fiber ruptures coming out of the bottom of the oxygenator.The pco2 came down slightly but was still in the mid to high 50s at a sweep of 10 l/min.The po2 remained relatively okay but by the end of the pump run the fio2 was 100% maintaining a po2 of 250.Towards the end of the case, when the ox ygenator started failing, the decision was made to try to come off pump and then change the oxygenator out instead of cooling and doing circ arrest again.They did make it off the pump okay (but still on max fio2 and sweep) but the patient expired in the or shortly after the pump run due to severe coagulopathy.

Manufacturer Narrative

Additional information: manufacturing date (25-05-2023) and expiry date (25-05-2025).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: 17481008
• MDR Text Key: 320601107
• Report Number: 2184009-2023-00878
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/04/2023

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: 07/20/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 08/09/2023
• Supplement Dates FDA Received: 09/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2023
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 104 KG