MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY NT HOLLOW FIBER OXYGENATOR TRILLIUM; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 511T

Device Problem Increase in Pressure (1491)

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

Event Date 03/02/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: visual inspection shows no outward signs of physical damage or abnormalities.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.Reason for return was not confirmed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of this custom tubing pack's nt oxygenator, high pressure was noted.Patient was scheduled for rvm with cec, heparinized in dose according to protocol with act control of 999 seconds, cannulation and admission to cec, with adequate pre-membrane pressures, adequate return and pump output, at 3 minutes a progressive increase in pressures was observed pre-membranes, hypotension and increased volume of the venous reservoir.Due to suspected cold agglutination, active heating of the circuit was started (patient at 36 degrees, and perfused at 35 degrees), no improvement detected in pressures.Heparin was added, the cec was removed and pressure flow tests performed for 10 minutes.With increased oxygenator, cec was restarted, observing the same phenomenon, this time albumin was added.Again, the cec was left, and tests carried out on the new membrane, with a slight decrease in pressures observed for which a partial bypass was attempted.Monitoring pre-membrane pressures with pressures at 2 liters, obtaining 400 mm/hg.Came out of cec again and procedure performed without a pump.There was no adverse effect to the patient.

Event Description

Medtronic received information that during use of this custom tubing pack's nt oxygenator, high pressure was noted.Patient was scheduled for rvm with bypass, heparinized in dose according to protocol with act control of 999 seconds, cannulation and admission to bypass, with adequate pre-membrane pressures, adequate return and pump output, at 3 minutes a progressive increase in pressures was observed pre-membranes, hypotension and increased volume of the venous reservoir.Due to suspected cold agglutination, active heating of the circuit was started (patient at 36 degrees, and perfused at 35 degrees), no improvement detected in pressures.Heparin was added, bypass was removed and pressure flow tests performed for 10 minutes.With increased oxygenator, bypass was restarted, observing the same phenomenon, this time albumin was added.Again, bypass was left, and tests carried out on the new membrane, with a slight decrease in pressures observed for which a partial bypass was attempted.Monitoring pre-membrane pressures with pressures at 2 liters, obtaining 400 mm/hg.Came out of bypass again and procedure performed without a pump.There was no adverse effect to the patient.

Manufacturer Narrative

Medtronic investigation: complaint was not confirmed.Device was returned and visual inspection showed no outward signs of physical damage or abnormalities.Unit appeared to have been used.Pressure integrity testing shows no internal or external leaks.Performance testing results were compared to historical test results of other used trillium coated affinity oxygenators.Blood side pressure drop was at 100 mm/hg, as compared to historical average of 116.82 mmhg.Therefore, the reason for return was not confirmed.Comparison of blood side pressure drop cannot be done directly to specification as the oxygenator is in a different state once used so results are compared to historical averages.As observed from returned devices, stagnant blood clots and would affect blood flow through the device.A dhr review was conducted and did not identify any anomalies or deviations in the manufacturing process which would cause or contribute to the reported incident.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 anticoagulation protocol.The ifu for the affinity nt oxygenator 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 against 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.There are no current trends and no further actions are required.This investigation was completed with the information that was provided, if additional information is received, this investigation will be reopened if deemed necessary.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.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 NT HOLLOW FIBER OXYGENATOR TRILLIUM
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 11601486
• MDR Text Key: 244385491
• Report Number: 2184009-2021-00018
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K191029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 511T
• Device Catalogue Number: 511T
• Device Lot Number: 13342147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 04/01/2021
• Supplement Dates Manufacturer Received: 03/03/2021
• Supplement Dates FDA Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1