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

Model Number BB811

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: visual inspection shows no outward signs of physical damage or abnormalities.Unit appears to have been primed.Pressure integrity t esting 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 device.The device was cut apart and the leak is from the bond between the blood side to atmosphere.A guide wire was able to be inserted through the groove.Reason for return was confirmed.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 prior to use of a fusion oxygenator, it was reported that the device leaked.The device was primed the day before the procedure and not used.It sat overnight and the next day, it was found to have a leak.The customer described the leak towards the top of the oxygenator, near the arterial filter side.The customer also noticed entrained air possibly coming from the fiber side of the oxygenator as if there was a crack, but could not visually see one.The device was replaced.There was no patient involvement, so no adverse effect occurred.There was no reported damage to the plastic housing or container that the oxygenator was received in. no damage was observed to the oxygenator itself at set up or noticed when assembled.Medtronic received additional information that the physician said the leak was not at the tubing connection or the connection.The leak seemed to be from the top of the oxygenator near the recirculation line.There was a bubble in the oxygenator possibly coming from the fibers according to the physician.However, it may have just come from the leak as well.

Manufacturer Narrative

Conclusion: complaint confirmed for the fusion oxygenator's leak.The issue was verified via analysis of the returned device.Review of this unit¿s device history record found no abnormalities or ncmrs initiated during manufacturing that would cause or contribute to the reported event.This unit passed all testing and inspections during manufacturing, however, this was likely an error during manufacturing.The issue will be addressed by notifying manufacturing personnel during quarterly product quality meetings.There were no patient/clinical safety issues reported.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.

• 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: 16859626
• MDR Text Key: 314453416
• Report Number: 2184009-2023-00225
• 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: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: BB811
• Device Catalogue Number: BB811
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2023
• 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