MAUDE Adverse Event Report: PERFUSION SYSTEMS MEDTRONIC TUBING PACK; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	BB10M79R8
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	11/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is indicated as returning.Evaluation will be conducted following receipt of the device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during use of the custom pack the accessory line came apart during the case of a patient 6 days on ecmo.The line was replaced to complete the case.Patient had a blood loss of approximately 50-100cc¿s.1-unit of blood was given after the line failed.No other adverse patient effects were reported.
Additional Manufacturer Narrative
D10: device was discarded by customer conclusion; it was determined the user used this product outside of its indicated use as it was used on a 6 day ecmo and this product is only for use in cbp procedures.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.

• Brand Name: MEDTRONIC TUBING PACK
• 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: 9459334
• Report Number: 2184009-2019-00081
• Device Sequence Number: 11302635
• Product Code: DWF
• UDI-Device Identifier: 00763000180713
• UDI-Public: 00763000180713
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/07/2021
• Device Model Number: BB10M79R8
• Device Catalogue Number: BB10M79R8
• Device Lot Number: 217570547
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention