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

Model Number BB811

Device Problem Increase in Pressure (1491)

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

Event Date 10/25/2022

Event Type  Injury  

Manufacturer Narrative

Device evaluation summary: visual analysis: visual inspection showed no outward signs of physical damage or abnormalities.The unit appeared to have been used.The device was cleaned using a renalin solution.Pressure integrity testing showed no internal or external leaks when run at 3 lpm 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) and the results were 206 mmhg blood side pressure drop.Reason for return was undetermined.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.

Event Description

Medtronic received information that during use of a fusion oxygenator, the customer reported a high delta p, 5 minutes after bypass.See attached perfusion records.The device was replaced to complete the procedure.There was no patient impact associated with this event.The following procedure details were reported: 12.20-12.30 p.M.: preparation of the heart-lung machine (hlm) 13.00 p.M.: incision and preparation time 13.53 p.M.: heparin delivery by anaesthesia 50000 i.U.And additionally 10000 i.U.Into the hlm heparin-natrium_leo, 25000 i.U./ 5 ml, batch: c46320, expiry date: 6/2023 13.59, 14.01 p.M.: suction on at act >400s, bypass start with one cannula, therefore half flow 2.03 p.M.: 2nd cannula; under full flow, pressure alarm 550mmhg pre oxy all connections are checked, a problem communicated as no fault could be found.Parallel provided by 2nd hlm, pressure limits adjusted to 600/550 mmhg.14.05 p.M.: act stops at 765s, a control measurement 14.15 p.M.At 650s 14.07 p.M.: at dp >330mmhg below 60% flow, in consultation with upgrading the replacement machine with values kept stable by anaesth esia.2.10 p.M.: bypass checked and finished for hlm exchange, afterwards problem-free intervention and completion of the procedure possible.The anaesthetist gave the patient prophylactic at iii saturation and a full dose of heparin.Second bypass start at act > 1000s.The patient's blood volume from the first hlm was prepared via cellsaver and returned.When draining, the blood could only be pumped from the oxygenator into the transfer bag or flushed through the vent lines with "squeaking and foaming".Medtronic received additional information that jonosteril and heparin were used in prime or during the case.The pressure measured in the circuit was pre 500mmhg, automatic stop at 550 mmhg.A hemochron act diagnostic device was used to monitor heparin dosing to achieve optimal therapeutic response.The temperatures pre and post oxygenator were; pre 36°c, post 35°c.The second oxygenator used was not a medtronic oxygenator.

Manufacturer Narrative

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

Conclusion: complaint not confirmed for the fusion oxygenator's high-pressure excursion.The issue was not verified via analysis of the returned device.Visual analysis of the returned device showed no outward signs of physical damage or abnormalities, and no leaks were observed during pressure integrity testing.Blood lab testing at 7lpm blood and gas flows resulted in a pressure drop of 206 mmhg across the blood side of the device.Blood side pressure drop is used as an indicator for device flow and pressure drop performance, and the returned device performed as expected.Review of this devices¿ 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.It is suspected the high pressure experienced by the customer may be related to a cold induced protein build up or cryoprecipitate which caused initial flow restriction in device, or the patient or clinical condition at the time of bypass or related to heparin potency.The root cause is undetermined.Trends for issues with this product are reviewed at quarterly quality meetings.Correction additional codes imf/annex f: this code has been updated.Correction b5: there were no adverse patient effects associated with this event.Correction g4.4 (pma/510k #): this field has been updated.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: 16014167
• MDR Text Key: 305843020
• Report Number: 2184009-2022-00440
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K203111
• 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,Followup,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 02/18/2024
• Device Model Number: BB811
• Device Catalogue Number: BB811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 12/20/2022; 01/20/2023
• Supplement Dates FDA Received: 01/18/2023; 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2022
• 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: 27 YR
• Patient Sex: Female