MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO-MEDICUS LIFE SUPPORT TM; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	LS96218-017
Medical Device Problem Codes	Crack (1135); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of a bio-medicus life support cannula, the customer reported that small cracks were observed in the coupling piece.The device was used to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that there wasn't any leak from the cannula, or from the connection between a cannula and a connector.There was no patient blood loss.No transfusion was required.The cannula was not heated or cooled prior to use.There was no damage in the location of the sutures.Medtronic received additional information that this device was being used for an ecmo procedure.There was no injury related to the cannula.
Additional Manufacturer Narrative
Continued from d4 lot #: it was reported that the lot number is probably 224715948, the customer was not sure.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.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Conclusion: after investigation the complaint is confirmed for a cracked cannula body connector based on the photo provided, however, no product has been returned.It is unknown what may have caused this occurrence, however, based on the available information this complaint could be the result of a use-related issue.This damage to the cannula connector can occur when the introducer is inserted into the cannula body without the use of the hemostasis cap.The introducer handle can cause stretching, crazing, or cracking when it is forced into the connector.The issue is more likely to occur with the arterial cannulae models with a clear hemostasis cap that is attached to the introducer on the provided clear protective sheath.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.A manufacturing investigation was completed for this fai lure mode in this investigation the manufacturing process was reviewed, and the handle of the affected part is minimum, just pick and place into the packaging, no additional assembly.Review of in-process pictures showed that the pieces produced are in good condit ion.Product event notification and awareness was given to the production personnel about the implications and consequences that reported defect has on the field.Complaints received for similar model numbers were reviewed and showed no trends warranting escalation related to this occurrence.There were no adverse patient effects because of this incidence.Medtronic will continue to monitor for future occurrences and trends.Correction e (street 1) and e (region): these fields have 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: BIO-MEDICUS LIFE SUPPORT TM
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• 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: 16895119
• Report Number: 2184009-2023-00240
• Device Sequence Number: 20322434
• Product Code: QHW
• UDI-Device Identifier: 00763000615420
• UDI-Public: 00763000615420
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K201057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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: 09/02/2025
• Device Model Number: LS96218-017
• Device Catalogue Number: LS96218-017
• Device Lot Number: 224715948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 07/17/2023
• Date Device Manufactured: 09/02/2022
• 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