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

Model Number BB811

Device Problem Fluid/Blood Leak (1250)

Patient Problems Death (1802); Neurological Deficit/Dysfunction (1982)

Event Date 10/21/2019

Event Type  Death  

Manufacturer Narrative

Suspect medical device.: the following fusion oxygenator lots were used in the manufacture of perfusion pack m332710k lot: 217755702: lots13300580 and 13300598: 13300580 date of manufacture: 15 may 2019 expiry date: 31 may 2021 13300598 date of manufacture: 16 may 2019 expiry date: 31 may 2021.The actual lot number and expiry date of the device will be available once it has been returned to medtronic.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of a perfusion tubing pack and fusion oxygenator the customer observed clotting around the surface of the oxygenator at the start of bypass.A blood leak was observed at the venous line entrance to the oxygenator towards the end of bypass, approximately 1.5 hrs into the procedure.The products were replaced to complete the case.The patient had a neurological complication (thrombotic stroke) following the procedure in the recovery unit.The patient expired two days after surgery.

Manufacturer Narrative

Visual analysis: visual inspection shows evidence of clotting inside the device.Performance analysis: 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 were no leaks observed from the inlet port.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

Medtronic investigation: the report of a leak at the oxygenator venous line entrance was unable to be replicated at medtronic.The returned device was cross-sectioned showed evidence of blood staining throughout the fiber bundle (protein build-up), but no clear location or start of clotting.No manufacturing errors were identified.Flow was established while cleaning the device, indicating that the device itself did not have blockages.Additional visual inspection showed no outward signs of any damage or assembly errors.A clinical review of this event concluded that the clinical information and analysis of the device does not indicate a device malfunction related to this occurrence.The fibrin/clots may be patient-related or due to the clinical situation (potential temperatures extremes, heparin potency challenges or unintended air within the circuit), rather than a malfunction of a medtronic device.The use site was unable to confirm if the patient outcome was a result of a malfunction to a medtronic device.The device history record was reviewed; no abnormalities were documented during the manufacture of this product to indicate the product did not meet manufacturing specifications that would contribute to this occurrence.Trends for issues with this product are reviewed at quarterly quality meetings.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 perfusion tubing pack and fusion oxygenator the customer observed clotting around the surface of the oxygenator at the start of bypass.A blood leak was observed at the venous line entrance to the oxygenator towards the end of bypass, approximately 1.5hrs into the procedure.The products were replaced to complete the case.The patient had a neurological complication (thrombotic stroke) following the procedure in the recovery unit.The patient expired two days after surgery.

• 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: 9267426
• MDR Text Key: 165946001
• Report Number: 2184009-2019-00064
• 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,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2021
• Device Model Number: BB811
• Device Catalogue Number: BB811
• Device Lot Number: 13300598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 51 YR
• Patient Weight: 83