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

Model Number BBP241

Device Problem Restricted Flow rate (1248)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 04/05/2021

Event Type  Injury  

Manufacturer Narrative

Initial analysis: visual inspection of the returned complaint device showed no outward signs of any damage/assembly errors.During the cleaning process there were no flow issues or obstructions observed.Following further assessment, a summary of medtronic's investigation and conclusion will be provided in supplemental mdr report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use, the customer reported the affinity pixie cardiotomy/venous reservoir (cvr) had a temporary flow issue.During cardiopulmonary bypass there was a sudden decrease in the cvr level.Due to this reason, they had to reduce the master pump flow for a couple of minutes with a significant decrease in blood pressure and patient nirs value.The customer stated that the addition of 100 ml blood and 50 ml albumin was required as a direct consequence of the device issue.They also stated that visually it seemed the flow of blood through the filter of the reservoir was very slow and they saw blood coming from the top of the filter.In a couple of minutes, the issue resolved with no further intervention needed.The device was used to complete the case.There was no adverse effect to the patient.Additional information from the customer: operation: asd closure.Calculated blood flow: 1.831 l/min.Act was 600 sec.Nirs= nears i nfrared spectroscopy (a non-invasive and real-time diagnostic technique, capable of measuring tissue oxygenation (sto2 cerebral)).During the procedure they used suckers and vent.Vacuum assist only during the event.

Manufacturer Narrative

Investigation summary: complaint confirmed for the pixie cvr's low flow issue.The issue was verified via the customer-provided photos and video, however, performance analysis of the returned device did not replicate the issue.No flow issues or obstructions were observed when cleaning the 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 required testing and visual inspections during manufacturing.The root cause is undetermined.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: 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: 11769521
• MDR Text Key: 248804129
• Report Number: 2184009-2021-00027
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: BBP241
• Device Catalogue Number: BBP241
• Device Lot Number: 13321149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 15