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

Model Number BB841

Device Problem Obstruction of Flow (2423)

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

Event Date 03/02/2022

Event Type  Injury  

Manufacturer Narrative

Product analysis: visual inspection showed evidence of a blockage in one of the luer fittings.The blockage appears to be a section of a luer stem.The blockage was not able to be easily removed.During the cleaning process there was little to no flow through the luer fitting.The reason for return was confirmed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of a fusion cardiotomy venous reservoir (cvr), it was reported that there was extremely limited flow through the sample manifold.The customer suspects that there was solvent or some other substance blocking the arterial male luer end of the manifold line.They were able to draw samples using other methods during the case and no changeout was required.The device was used to complete the procedure.There was no patient impact associated with this event.Additional information received states that the customer was able to draw samples using other methods during the case by connecting a pigtail with 3 way stopcock to a luer port on the recirculation line which gave them access to the arterial blood.

Manufacturer Narrative

Conclusion: the complaint is confirmed for the blockage and low flow through the arterial male luer end of the fusion cardiotomy venous reservoir (cvr) manifold line.The issue was verified via analysis of the returned device, which showed evidence of a blockage.This blockage appeared to be a section of a luer stem.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.Trends for issues with this product are monitored.Correction: d4.2 and h4 have been corrected.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: RESERVOIR, BLOOD, 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: 13964493
• MDR Text Key: 288283957
• Report Number: 2184009-2022-00059
• Device Sequence Number: 1
• Product Code: DTN
• 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 Assistant
• Type of Report: Initial,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/13/2022
• Device Model Number: BB841
• Device Catalogue Number: BB841
• Device Lot Number: 13363052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2020
• 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): Required Intervention