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

Model Number	HY7F85R16
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of this custom pack, the customer reported that after the procedure was completed they were removing the pump header tubing and noticed that a crack was in the tubing.The perfusionist discovered the crack at the end of the case when flushing clear solution thru the tubing.The tubing was in positive pressure since it was located in the roller head of the heart lung machine.No fluid had leaked during or after the procedure.The device was used to complete the procedure.There was no patient impact associated with this event.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows a evidence of damage/crack in the returned section of tubing.Reason for return was confirmed.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Conclusion: after evaluation the cause of this complaint could not be determined.Complaints received from (b)(6) 2021 through (b)(6) 2022 for the same failure mode were reviewed and showed no trends warranting escalation related to this occurrence.Assessment against the risk management file showed that the current risk zone does not exceed the risk zone predicted in the product pfmeca; therefore, no capa will be initiated at this time.There were no adverse patient effects because of this incidence.Trends for issues with this device are monitored.The manufacturer name, street, city, region, country code and post code have been corrected in section d.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.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 MN 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc MN 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 13010239
• Report Number: 2184009-2021-00120
• Device Sequence Number: 4926148
• Product Code: DWE
• UDI-Device Identifier: 00763000287719
• UDI-Public: 00763000287719
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

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: 11/20/2022
• Device Model Number: HY7F85R16
• Device Catalogue Number: HY7F85R16
• Device Lot Number: 221536178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2021
• 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