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

Model Number BB9N38R12

Device Problems Fluid/Blood Leak (1250); Material Deformation (2976)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/08/2022

Event Type  Injury  

Manufacturer Narrative

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 Description

Medtronic received information that during use of a custom tubing pack, the customer reported that the vent valve lost one of the rubber one-way valves, this caused the device to leak blood.About 200 to 250 ml of blood was spilt on the floor.The patient required a blood transfusion because of the blood loss from the leak.The device was replaced to complete the procedure.There was no additional patient impact associated with this event.

Manufacturer Narrative

Medtronic received additional information that the leak appeared only in one pack.There was visible air on the vent line.During the incident, it was filled with blood which was leaking on the floor.Medtronic received additional information that the valve was placed on the negative side of the pump by the customer in the sterile field.There was only negative, gravity or patient pressure on the valve during use.The leak detected during the procedure.The pump model used was a non medtronic roller pump, unknown revolutions when failure occurred.The customer stated that the flow and pressure were unknown as they were giving retrograde cardioplegia when the failure occurred at a coronary sinus pressure of 30.The vent valve was used as normal for the procedure.The customer stated that they do not test the valve as it is at the table about ¼ inches of tubing off the antegrade/aortic root spoker for vent.The customer uses the antegrade with a y.Then ¼ inch tubing then valve then tubing back to the pump and they never see or inspect it as it is opened by a nurse and put in place by someone in the surgical field.The customer stated that vent valves are to be tested prior to using and when they are on pump, it¿s inspected when the "customer" first turns it on.The customer used antegrade and retrograde.Investigation performed confirms the complaint for leaking per the photo provided by the client.Analysis has not been performed as device has not been returned to date.There were no adverse patient effects because of this incidence.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.

Manufacturer Narrative

Device evaluation summary: visual inspection showed one of the umbrella valve was loose from the device.During the cleaning process there was leaking observed from the negative umbrella valve location.Reason for return was confirmed.Conclusion: the reported complaint was confirmed for leaking per the product analysis from laboratory, review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.There is a potential this was caused by the supplier.The supplier will be notified about these issues.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
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15796068
• MDR Text Key: 303630692
• Report Number: 9612164-2022-04234
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K171979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2024
• Device Model Number: BB9N38R12
• Device Catalogue Number: BB9N38R12
• Device Lot Number: 224414911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 12/05/2022; 01/04/2023
• Supplement Dates FDA Received: 12/15/2022; 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention