MAUDE Adverse Event Report: PERFUSION SYSTEMS PEDIATRIC BIOMEDICUS FEMORAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	96820-008
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2020
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 bio-medicus one-piece femoral arterial cannula, it was noted that there was blood leaking from the middle part of the cannula that was inserted into the patient.It was asked but unknown how much blood leaked.A transfusion was not required.The cannula was removed and it was seen that it was ripped from the wire winding middle part.No damage was observed to the cannula prior to use.The customer stated the damage to the cannula was not caused by the sutures.The cannula was replaced to complete the case.There were no patient adverse effects as a result of the reported issue.
Additional Manufacturer Narrative
Visual analysis: visual inspection shows the device is damaged/split.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
Visual analysis: visual inspection shows the device is damaged/split.Device was cleaned using a 10% bleach solution.Conclusion: after analysis of this complaint a root cause could not be determined.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.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: PEDIATRIC BIOMEDICUS FEMORAL CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 9646303
• Report Number: 2184009-2020-00008
• Device Sequence Number: 11556228
• Product Code: DWF
• UDI-Device Identifier: 00613994530707
• UDI-Public: 00613994530707
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K872033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2020

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: 01/31/2023
• Device Model Number: 96820-008
• Device Catalogue Number: 96820-008
• Device Lot Number: 2019010396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/05/2020; 03/18/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 03/03/2020; 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1