MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY PIXIE HFO AND PIXIE CVR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BBP241

Device Problems Fluid/Blood Leak (1250); Obstruction of Flow (2423)

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

Event Date 10/11/2021

Event Type  malfunction  

Manufacturer Narrative

Conclusion: complaint confirmed for the pixie cvr's oozing flow issue.The issue was verified via the customer-provided photos, which also show the pressure relief valve inside the jar.A loose or absent pressure relief valve could have contributed to the blood flow/oozing issue observed.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 required inspections and testing during manufacturing.A previous investigation into complaints for the pressure relief valve falling into the pixie cvr, and suggests the following potential root causes: dimensional design of the valve and valve seat, a new injection molding tool qualified in 2018, insertion of the obturator cap during manufacturing and/or use-related manipulation of the cap and valve, use of vavd, and physical shock and/or material property changes during sterilization, shipping, and storage.Root cause is undetermined.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.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 the pixie cardiotomy venous reservoir (cvr) blood oozing was observed.The cvr was replaced.There were no adverse patient effects as a result of this issue.Additional information received from the customer stated that the clinical evaluation of blood loss was about 50ml and a blood transfusion was not required.Information on the exact location of the blood oozing was requested but the customer stated that they were unable to provide more information.

• Brand Name: AFFINITY PIXIE HFO AND PIXIE CVR
• 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: 17127201
• MDR Text Key: 317873230
• Report Number: 2184009-2023-00532
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K183511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: BBP241
• Device Catalogue Number: BBP241
• Device Lot Number: 13372874
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2021
• 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