MAUDE Adverse Event Report: PERFUSION SYSTEMS FUSION HOLLOW FIBER OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BB811

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

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

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: visual inspection shows evidence of damage/cracks in the bottom cap.The damage is to the portion that separates the water from the air side, when water was connected to the water inlet port and then engaged there was a leak from the bottom of the device.Reason for return was confirmed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that prior to use of a fusion hollow fiber oxygenator, the customer reported that after set-up, water flowed out of the bottom of the oxygen stir.The device was replaced.There was no patient involvement so no adverse effect occurred.Medtronic received additional information via analysis of the returned device that the leak was due to a crack at the bottom of the oxygenator.Medtronic received additional information that the device itself leaked.The leak was located at the bottom of the device.There was no damage to the device, the packaging or other contents within the package (ex.Devices in a tray or custom pack).

Manufacturer Narrative

Conclusion: the complaint was confirmed for the fusion oxygenator's damaged/cracked bottom cap.The issue was verified via analysis of the returned device.Damage was noted on the portion that separates the water side from the air side, and a leak was noted from the bottom of the device when water was connected to the water inlet port.This type of damage would not be acceptable during manufacturing.Review of this unit¿s device history record found no abnormalities or non-conforming material reports (ncmrs) initiated during manufacturing that would cause or contribute to the reported event.This device passed all testing and inspections during manufacturing.The root cause is unknown, but potentially related to damage occurring during shipping or storage.There were no patient/clinical safety issues reported.Trends for issues with this product are reviewed at quarterly quality meetings.Correction section d unique identifier: this field has been updated.Correction h8 usage if device: this field was updated to initial.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: FUSION 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: 15370156
• MDR Text Key: 304686129
• Report Number: 2184009-2022-00243
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00643169178168
• UDI-Public: 00643169178168
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183490
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/31/2023
• Device Model Number: BB811
• Device Catalogue Number: BB811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2022
• 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