MAUDE Adverse Event Report: PERFUSION SYSTEMS OXY/CVR COMBO BB841 FUSION W/BALANCE 26L; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BB841

Device Problem Air/Gas in Device (4062)

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

Event Date 02/12/2024

Event Type  malfunction  

Event Description

Medtronic received information that during use of a fusion cardiotomy venous reservoir, the customer reported material in the reservoir during bypass.The use of the device was unspecified.There was no adverse patient effect associated with this event.

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

The device was used to complete the procedure.A venous cdi cuvette was connected to the venous line at the end of line 19 and start of line 23 on the technical drawing.The sample manifold line (line 6 of the technical drawing) was run into the venous inlet drain tube angled luer.Correction b5: medtronic received additional information that there were no venous air events.The customer ran the sample manifold into the venous inlet as recommended.The customer stated that large amounts of suction were not used during the case.The customer stated that the patient needed an aortic valve replacement so bleeding was minimal.Haemoconcentration was not used during the case.Co2 insufflation was used during the case but the customer had not seen this phenomena in other cases in which they had used co2 insufflation.Bypass began at 9.36 am, and this was first observed at 10.32 am (approximately 56 minutes in) the customer stated it had gotten much worse by 10.53 am.The customer stated that patient came off bypass by 11.12 am, so there was not much time to consider a change in practice.It was stated that there were no anomalies with the patient just dyslipidemia and hypertension, as is typically seen in this population of patients.The customer stated the patient did really well from the mdt (mdt is the department medical review meetings of recent cases).The customer stated that they were told that fibrin could sometimes be seen outside of the filter due the way the cardiotomy was built (a higher cardiotomy sock, and the yellow plastic deposits fibrin when it is exposed to it), but the customer stated that do not believe this is fibrin.Correction h6.2 (eval code method (fdm/annex b)): this code has been updated.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Additional information: manufacturing date (2023-09-30) and expiry date (2025-09-30).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Additional info b5: medtronic received additional information that the venous line was not partially obstructed in any way.The customer had a venous cuvette in the venous line as per protocol, as this is part of the minimum standard of monitoring.There was nothing else on the venous line.A vacuum assisted venous drainage used (vavd) was not used.The purge line was open, and it was connected to the other side of the venous inlet.The customer had the sampling manifold going in on the left and the purge line going in on the right.Please see attached perfusion records.Correction a2: update to the patients age additional info a4: patients weight added medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: OXY/CVR COMBO BB841 FUSION W/BALANCE 26L
• 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: 18777193
• MDR Text Key: 336305844
• Report Number: 2184009-2024-00097
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K230640
• 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,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: BB841
• Device Catalogue Number: BB841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2024
• Date Device Manufactured: 09/30/2023
• 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 Age: 83 YR
• Patient Sex: Female
• Patient Weight: 57 KG