MAUDE Adverse Event Report: PERFUSION SYSTEMS DLP SINGLE STAGE VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	66116
Medical Device Problem Codes	Material Puncture/Hole (1504); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 single stage venous cannula, the customer reported that a break/hole in the cannula was noted.The cannula was sutured to the sternal retractor with the 1st suture, approx.5-7 cm up from the tip.This caused the cannula to suck air during use.After two hours of perfusion and after weaning the patient, the staff involved saw a large hole in the venous cannula.The venous cannula was almost completely divided into two parts.The suture was loosely tied to the cannula and the sternum retractor.There was no patient impact associated with this event.
Additional Manufacturer Narrative
No transfusion was required as there was no blood loss.The cannula was not heated or cooled prior to use.The damage was not in the location of the sutures.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
Product analysis: visual inspection showed evidence of a split in the cannula body.The device was cleaned using a 10% bleach solution.During the cleaning process there was no evidence of a leak from the split.The reason for return was confirmed for damage.Conclusion: the complaint is confirmed for damage to the cannula body.It is unknown what may have caused this occurrence, however, there is the possibility the damage was caused by the suture used to secure the cannula to the retractor.Additional inspection under magnification observed internal cloudiness and jagged edges in two places on the returned device and in those areas, the wire was exposed.A bend test of the cannula body is performed during manufacturing.If during the visual and functional test quality checks a defect such as the returned device were to have been found, the lot would be placed on hold as splitting, and exposed spring are listed as critical defects.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.Trends for issues with this device are monitored.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: DLP SINGLE STAGE VENOUS CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12647715
• Report Number: 2184009-2021-00095
• Device Sequence Number: 6123255
• Product Code: DWF
• UDI-Device Identifier: 00613994878519
• UDI-Public: 00613994878519
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K845045
• 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): 01/20/2022

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: 10/14/2023
• Device Model Number: 66116
• Device Catalogue Number: 66116
• Device Lot Number: 2020100516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 12/21/2021; 12/21/2021
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 12/21/2021; 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2020
• 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 Age: 3 MO
• Patient Sex: Female
• Patient Weight: 6 KG