MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY HFO W/TRILLIUM 511T; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 95215

Device Problem Mechanical Problem (1384)

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

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: visual inspection shows no outward signs of physical damage or abnormalities.Unit appears to have been used.There was a crack in the arterial sampling port.The arterial sampling port was bonded and pressure integrity testing shows no internal or external leaks when run at 3 l/pm with 23 psi, (1189 mmhg) of back pressure for 10 minutes.The device was sent to the blood lab for performance testing.Testing was conducted at a 1:1 ratio (7lpm blood & gas flows) the results were compared to historical test results of other used trillium-coated affinity hfo¿s.Blood side pressure drop was at 112 mm/hg, as compared to historical average of 116.61 mmhg.Reason for return was not confirmed for flow issues.The device was returned and visually inspected.A crack was observed on the arterial sampling port.It is unknown if this happened before, during, or after the reported event.Returned product not shipped in protective packaging can lead to product damage; however, this can not be verified.The observed crack may lead to a small leak but would not have a significant effect on flow so these items are not related.Performance testing was conducted.The pressure drop was as expected and analysis could not duplicate the reported event so no flow related discrepancies were found.A review the dhr found no anomalies and most of the blood lab testing was as expected, this suggests the device was physically man ufactured appropriately.The exact cause is unknown but there is a potential that a protein build up or cryoprecipitate event occurred.Although it may have been momentary, this could affect the fiber even if the majority of the case maintained an acceptable ant icoagulation protocol.The ifu for the affinity nt hfo states the following; a strict anticoagulation protocol should be followed, and anticoagulation should be routinely monitored during all procedures.The benefits of extracorporeal support must be weighed aga inst the risk of systemic anticoagulation and must be assessed by the prescribing physician.Adequate heparinization must be maintained before and during bypass.Trends for issues with this product are reviewed at quarterly 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.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

Medtronic received information that during use of this nt oxygenator after starting bypass the customer was unable to import the flow and there was resistance to the oxygenator.As a result the surgeon decided to use an octopus to perform the surgery.There were no adverse patient effects as a result of this issue.Additional information: the nt oxygenator was replaced once the flow issues were noted.The oxygenator was primed with ringer lactate serum, 1 hour before use.

• Brand Name: AFFINITY HFO W/TRILLIUM 511T
• 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: 17097864
• MDR Text Key: 317771538
• Report Number: 2184009-2023-00479
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K191029
• 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: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 95215
• Device Catalogue Number: 95215
• Device Lot Number: 13317764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2020
• 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
• Patient Sex: Male