MAUDE Adverse Event Report: MEDTRONIC MEXICO CUSTOM TUBING PACK; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number	HY6V11R35
Medical Device Problem Code	Misassembled During Installation (4049)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows the luer fitting is separated from the tubing.Device was cleaned using a 10% bleach solution.Additional visual inspection shows evidence of solvent residue.Reason for return was confirmed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during use of this custom tubing pack during extra corporeal membrane oxygenation (ecmo), it was noted that luer connection separated from 1/8 tubing that it was attached to.Perfusion then reinserted the tubing onto the luer connection.Perfusion then replaced the 1/8 male luer line with another back up line they had in this pack and continued the case.Patient impact was requested but it will not be provided.Blood loss was minimal according to the hospital contact (no specific amount was given).No transfusion was reported.
Additional Manufacturer Narrative
Investigation conclusion: complaint is confirmed for the disconnection of component m333114d001.After investigation the cause of this complaint 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 will continue to monitor for future occurrences and trends.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: CUSTOM TUBING PACK
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 12172110
• Report Number: 9612164-2021-02737
• Device Sequence Number: 887475
• Product Code: DWE
• UDI-Device Identifier: 00763000402624
• UDI-Public: 00763000402624
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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: 09/17/2022
• Device Model Number: HY6V11R35
• Device Catalogue Number: HY6V11R35
• Device Lot Number: 222266708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 08/30/2021
• 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