MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY PIXIE PEDIATRIC HOLLOW FIBER OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BBP211

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 09/18/2020

Event Type  malfunction  

Event Description

Medtronic received information that during use of a pixie oxygenator, at the beginning of the case; at the pump time, before the cross clamp, an issue occurred.The perfusionist saw that there was a blood leak from the air outlet of pixie to the dry/oxygen air port.Approximately 15-20 cc blood was lost due to the leak.The device was replaced with another pixie to complete the procedure with no issues.There was no patient impact associated with this event.Additional information from the sales rep: the perfusionist was worried about it because the air inlet could be clogged.The clinic have been using pixie oxygenators for 2 years and they have many experiences on it and this is the first event that they ever seen.There was no need to give a blood transfusion due to the leak.

Manufacturer Narrative

Device evaluation summary: the complaint was for a fiber leak with the evidence of blood staining observed on the top of the fiber bundle.When the device was cleaned there was evidence of a crack in the recirculation port.During the pressure integrity test there was a leak observed from the crack.There was no evidence of a fiber leak during the test, however it was visually confirmed with blood staining on the top of the fiber bundle.Reason for return was visually confirmed with blood staining on the top of the fiber bundle.Conclusion: complaint confirmed for the pixie oxygenator's fiber leak.The issue was verified via the customer-provided photo and analysis of the returned 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 leak testing and visual inspections during manufacturing.It is possible pressure from adjacent fiber wraps lead to the acceptable results during leak testing, and the fiber relaxed during further processing resulting in the leak.Root cause is undetermined.There were no adverse patient effects reported.Trends for issues with this product are reviewed at product 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.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AFFINITY PIXIE PEDIATRIC HOLLOW FIBER OXYGENATOR
• 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: 16904377
• MDR Text Key: 314993404
• Report Number: 2184009-2023-00253
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BBP211
• Device Catalogue Number: BBP211
• Device Lot Number: 13307971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2020
• 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