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

Model Number	CB9R13R10
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows the tie band was not returned with the device.Pressure integrity testing was performed at 0.5 l/pm with 23 psi, (1189 mmhg) of back pressure for 10 minutes.During the pressure integrity test there was a leak observed.Reason for return was confirmed.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.
Event or Problem Description
Medtronic received information that during use of a custom tubing pack, it was reported that the product started to leak at the junction of the luer port and outlet of myotherm.The device was replaced to complete the procedure.There was no patient impact associated with this event.
Additional Manufacturer Narrative
Additional information b5: medtronic received additional information that the connection was not noted to be loose during set up.Blood lose was less than 5cc¿s.No transfusion was needed.There was no air seen in the circuit.Correction section d3 manufacturer's name, street, city, region, country code, and postal code: this fields have been updated.Correction lot number: this field has been updated.Correction unique identifier number: this field has been updated.Correction section h evaluation summary attached: this box has been ticked as it should have been selected in the previous report for this event 2184009-2022-00315.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
Conclusion: complaint is confirmed for leaking.After evaluation 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.Current personnel were notified and warned about the consequences that this issue has on field.Raw material available was inspected in warehouse and no irregularities were detected.Complaints received from (b)(6) 2022 through (b)(6) 2023 through for the same failure mode were reviewed and showed no trends warranting escalation related to this occurrence.There were no adverse patient effects as a result of this incidence.Medtronic will continue to monitor for future occurrences and trends.Correction b5: medtronic received additional information that the connection was not noted to be loose during set up.Blood loss was less than 5cc¿s.No transfusion was needed.There was no air seen in the circuit.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 MN 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc MN 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15788092
• Report Number: 2184009-2022-00315
• Device Sequence Number: 5528565
• Product Code: DWE
• UDI-Device Identifier: 00763000574611
• UDI-Public: 00763000574611
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K924529
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2023

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: 06/17/2024
• Device Model Number: CB9R13R10
• Device Catalogue Number: CB9R13R10
• Device Lot Number: 224699956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 11/14/2022; 03/21/2023
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 12/09/2022; 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2022
• 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