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

Model Number BB811

Device Problem Increase in Pressure (1491)

Patient Problems Death (1802); Hypoxia (1918); Brain Injury (2219)

Event Date 05/06/2020

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during a planned heart operation (cabg), the customer reported high pressure during use of the perfusion pack's oxygenator.Hlm primed med 1100 ml ringer, 100 ml mannitol, 10 ml mannitol, 10 ml cyclekapron, 10000ie heparin.Standard prime.Act measure 550 before ecc start.Start of ecc med full flow of 5.2 l/min of normal pre and post membrane pressure.Around 5 to 10 minutes after ecc start the pressure pre membrane rises to higher than 500 mmhg, post membrane normal pressure.Added 500 ml ringer to the heart lung machine in hope of reducing the pre membrane pressure.But pressure is not dropping.The surgeon changed out the cannula without any effect on the high pressure.The surgeon and perfusionist then decided to change out the oxygenator on beating heart, there is no x-clamp placed.Perfusion stopped, oxygenator changed, perfusion started again after approximately 4 minutes.Normalized pressure before the oxygenator at 270/140 mmhg.Perfusion time 109 minutes.Patient is going to intensive care as usual.It was reported that the patient never woke up post op.

Manufacturer Narrative

Additional information received reported that the patient sustained severe ischemic brain damage, which in all likelihood is a consequence of the above event.As a result of the severe brain injury active treatment was discontinued, and the patient went died.Other anamesis: in the past essentially well, with a possible unrecognized hypertension.Missed stemi as a prelude to the above intervention.Turns out to have a 3- vessel coronary artery disease.No significant valve pathology.Moderate reduced pump function equivalent to left heart chamber.Device evaluation summary: visual analysis: visual inspection shows no outward signs of physical damage or abnormalities.Device was returned with evidence of blood staining in the fiber bundle.The device was cleaned using a renalin solution.Performance analysis: 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.Testing was conducted at a 1:1 ratio (7lpm blood / gas flows) the results are as follows: 206 mmhg blood side pressure drop conclusion: reason for return was undetermined.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.

• Brand Name: FUSION HOLLOW FIBER OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 10082765
• MDR Text Key: 195412083
• Report Number: 2184009-2020-00026
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K172626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/31/2022
• Device Model Number: BB811
• Device Catalogue Number: BB811
• Device Lot Number: 13328942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Date Manufacturer Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 93