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

Model Number BBP241

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Sepsis (2067)

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that post use of a pixie oxygenator, the customer reported the patient had an infection and subsequently died from sirs and septic shock.

Manufacturer Narrative

Conclusion: based on the available information medtronic cannot confirm or deny the reported allegation against the pixie oxygenation system.This event was reported after execution of (b)(4) and is associated with a corrective and preventive action.A clinical review was performed with the office of medical affairs, post-market quality engineering, and microbiology.No device was returned to medtronic for analysis.Review of this unit's device history record found no abnormalities or non-conforming material reports initiated during manufacturing that would cause or contribute to the reported event.This unit passed all required testing and visual inspections during manufacturing.Additional information including event details, patient details, perfusion records, and the official cause(s) of the reported adverse events were requested but they were not available.The root cause is undetermined.Trends for issues with this product are reviewed.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

Upon execution of (b)(4) medtronic received information that post use of a pixie oxygenator and cardiotomy venous reservoir, the patient had an infection and subsequently died from systemic inflammatory response syndrome (sirs) and septic shock.The below additional information was requested but is unavailable: - the date of the event - official cause of death.

• 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
• MDR Report Key: 11775855
• MDR Text Key: 248991908
• Report Number: 2184009-2021-00031
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K183511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: BBP241
• Device Catalogue Number: BBP241
• Device Lot Number: 13339133
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death