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

Model Number BBP211

Device Problem Fluid/Blood Leak (1250)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2021

Event Type  Injury  

Manufacturer Narrative

Visual inspection shows evidence of a fiber leak with blood staining on the top and bottom of the fiber bundle.Performance analysis: pressure integrity testing was performed at 1 lpm with 23 psi, (1189 mmhg) of back pressure for 10 minutes.During the pressure integrity testing there were no leaks observed from the device.Conclusion: reason for return was visually confirmed; however, it was not replicated during pressure testing.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of this oxygenator after 35 minutes of bypass there was a plasma-leakage from the lower level of the oxygenator.The oxygenator started to make foam in the section above the lower connection and heat exchanger.There was no leak noted during preparation and de-airing pre ecc. the or teams set up increased surveillance of the leak, and the intervention continued to its end with a significant risk if the situation had deteriorated.Less than 50 ml of blood was lost due to the leak, and a transfusion was required.There is no adverse patient effects associated with this event.Additional information: the patient was kept at a low temperature to allow for a possible change of oxygenator.The team prepared a spare oxygenator to prevent a possible replacement if the problem worsened during the rest of the procedure.There were no hemodynamic consequences for the patient during the procedure and post-operative; however there was a significant risk to the patient if the oxygenator had to be changed.There was no damage to the device, the packaging or other contents within the package.Arterial and venous flow rates and pressures ranged from 1.37 l/min to 1.920 l/min depending on the patient temperature.Pressure from 88 mmhg to 200 mmhg.There was no air in the system/tubing.

Manufacturer Narrative

Correction d4: model # and catalogue number correction g4: pma / 510(k) # correction h3: device evaluated; evaluation summary attached in h10 of previous report.Investigation conclusion: complaint confirmed for the pixie oxygenator's leak.The issue was verified via the customer-provided photo and analysis of the returned device.Visual analysis of the returned device showed evidence of blood staining on the top of the fiber bundle and a crack in the recirculation port.Pressure integrity testing on the returned device did not result in any leaks.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.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.

Manufacturer Narrative

Correction h2.6: annex e (patient code) and annex c (eval code result) correction additional codes: annex f correction investigation conclusion: the previously submitted investigation conclusion mentioned a crack in the recirculation port of the device.This information was entered in error.A crack was not observed during the analysis of this device.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 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: 12525938
• MDR Text Key: 273198598
• Report Number: 2184009-2021-00084
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K183511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: BBP211
• Device Catalogue Number: BBP211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2020
• 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
• Patient Age: 31 MO
• Patient Sex: Male