MAUDE Adverse Event Report: PERFUSION SYSTEMS OXY/CVR COMBO BB841 FUSION W/BALANCE 26L; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BB841

Device Problem Obstruction of Flow (2423)

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

Event Date 02/04/2021

Event Type  malfunction  

Event Description

Medtronic received information that during use of the oxy/cvr combo device, the customer reported there was hold up behind the cvr's venous screen.The device was used to complete the case.There was no adverse effect to the patient.

Manufacturer Narrative

Device evaluation summary: the results of the analysis determined there were no manufacturing errors or damaged components specific to the venous section of the device that would cause or contribute to the hold-up reported in the venous screen.Reason for return was undetermined.Conclusion: complaint confirmed for hold up in the venous screen of the fusion cvr.Visual analysis of the returned product confirmed there was no product damage or manufacturing issues.The appearance of foam in the fusion cvr is most likely came from the venous side and not a cardiotomy issue.The potential cause for the foam phenomenon was likely due to a significant air insult through the venous line.However there are other potential contributing factors, such as patient or clinical condition at time of bypass, protein build-up, platelet activation, temperature extremes, low heparin protocols, or variability in heparin potency causing a faster decline in anti-coagulation than anticipated.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 which would cause or contribute to the reported occurrence.There were no patient/clinical safety issues reported.Trends for issues with this product are reviewed at quarterly quality meetings.This regulatory report is being submitted as part of a retrospective review and remediation per d00953163 as part of a capa action.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: OXY/CVR COMBO BB841 FUSION W/BALANCE 26L
• 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: 16807584
• MDR Text Key: 313929637
• Report Number: 2184009-2023-00196
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183490
• 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
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: BB841
• Device Catalogue Number: BB841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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