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

Model Number HY8C67R16

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/06/2022

Event Type  malfunction  

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 pack, it was reported that the connection of perfusion tubing to the bio-probe flow probe was loose.The customer stated that it appeared that the connection was tie banded but not bonded and it began to leak during the procedure.The customer re-positioned and added additional tie bands.It was stated that the loose connection resulted in blood loss.

Manufacturer Narrative

Additional information b5: the device was used for the remainder of the procedure.There was no additional patient impact associated with this event.The leak originated from the connection of the tubing to the flow probe.The positive side of the circuit leaked but did not pull air.About 100ml of blood was lost and the patient was transfused, however the need for transfusion was multi-factorial.No damage was noted on the packaging and no other devices in the same box were damaged.Conclusion: the complaint is confirmed for ¿loose connections¿ per the customer evidence.An analysis of this occurrence could not be performed without the returned product.After evaluation it was determined that the failure could possibly be attributed to the tie band not being correctly tight.For this reason, product event notification and awareness were given to the production personnel about the implications and consequences that reported defect has on the field.Additionally, it was confirmed that the connection is not bonded since assembly is made without using solvent or alcohol due to the restrictions of the bio-probe component.Even if the connection is not made all the way it does not mean that it is insecure, trying to force it manually can cause damage to the components.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.There were no adverse patient effects because of this incidence.Trends for issues with this device are monitored.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 that one of the tie bands was loose.The device is from mold cavity a.Pressure integrity testing was performed at 20 psi for 2 minutes.During the test, there was a leak observed form the tubing/device connection that had the loose tie band.The reason for return was confirmed.Conclusion: the complaint is confirmed for loose connections per the customer¿s evidence.Visual inspection showed that one of the tie bands was loose.After evaluation this complaint was determined to be a manufacturing-related issue.The tie band was not correctly tight.Product event notification and awareness was given to the production personnel about the implications and consequences that the reported defect has on the field.Additionally, it was confirmed that the connection is not bonded since assembly is made without using solvent or alcohol due to the restrictions of the bio-probe component.Even if the connection is not made all the way it does not mean that it is insecure and trying to force it manually can cause damage to the components.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.Complaints received for the same failure mode were reviewed and showed no trends warranting escalation related to this occurrence.Assessment against the medtronic risk management file process failure mode and effects analyses (pfmeca) document indicates that the current risk zone does not exceed the risk zone predicted in the product pfmeca.There were no adverse patient effects because of this incidence.Medtronic w ill continue to monitor for future occurrences and trends for this device.Correction b5:the customer stated that all the devices in the lot were tie banded but not bonded.The customer tried to push the tubing on further to ensure the connections were tight, then tie band.The customer reported that some flow probes have been damaged during this process.Medtronic received additional information that the leak occurred on one patient.The team then checked each flow probe after opening the new packs.Six of the flow probes were lose and needed replacement or tightening.Blood loss only occurred on one patient.For the remaining cases, either a new flow probe was added before priming or the perfusionist tightened and tie banded the flow probe depending on severity of looseness.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: 15275217
• MDR Text Key: 303158979
• Report Number: 9612164-2022-03150
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00763000535070
• UDI-Public: 00763000535070
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2024
• Device Model Number: HY8C67R16
• Device Catalogue Number: HY8C67R16
• Device Lot Number: 224196557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2022
• 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