MAUDE Adverse Event Report: PERFUSION SYSTEMS LEFT HEART VENT; SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYP

Model Number	12113
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
Medtronic received information that during use of a dlp left heart vent catheters, it was reported that after the vent was inserted into the patient, there was a very small blood leak (a few milliliters maximum) from the region of the luer lock connector.The device was replaced to complete the procedure.There was no adverse patient effect associated with this event.There was no blood loss and no damage seen to any packaging.
Additional Manufacturer Narrative
Conclusion: the complaint was confirmed for crack in the connector resulting in a leak.It is unknown what may have caused this occurrence.Additional inspection of the connection area under magnification observed what appeared to be a split/crack up against the luer port area on the connector.Also found was a white cloudiness in the opening of the cracked/split area.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.There were no adverse patient effects as a result of this incidence.Medtronic has made its supplier aware and will continue to monitor for future occurrences and trends per the product quality meetings procedure.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.
Additional Manufacturer Narrative
Device evaluation: visual inspection showed evidence of a crack in the connector at the base of the luer fitting.During the cleaning process there was evidence of a leak at the location of the crack.The reason for return was confirmed.Additional information b5: medtronic received additional information that the cannula was not heated or cooled prior to use.The customer stated that there was no damage observed on the cannula.No damage was noted to the packaging.The customer stated that there was no damage in the location of the sutures.Medtronic received additional information that there was a blood leak from the device but the leak was a few milliliters and the patient did not require blood or fluid administration because of the leak.The customer stated that the leak was only great enough to draw attention to the alleged fault with the product.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: LEFT HEART VENT
• Common Device Name: SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYP
• 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: 16740982
• Report Number: 2184009-2023-00168
• Device Sequence Number: 15108996
• Product Code: DTS
• UDI-Device Identifier: 00643169881334
• UDI-Public: 00643169881334
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K834039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/08/2024
• Device Model Number: 12113
• Device Catalogue Number: 12113
• Device Lot Number: 2021120570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 04/14/2023; 06/22/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 05/11/2023; 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown