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

Model Number BB8B89R3

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/03/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: visual inspection showed the tubing was separated from the valve.Additional visual inspection under magnification showed evidence of solvent residue.The 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.

Event Description

Medtronic received information that during use of a custom tubing pack, it was reported that the arterial filter purge line experienced a separation distal to the one way valve that is in the purge line.The customer quickly clamped the purge line proximal to the tubing separation.The device was replaced to complete the procedure.The customer stated that there was less than 50 cc of blood loss due to this event.There was no additional patient impact associated with this event.Medtronic received additional information that there was no damage to the packaging (outer box, inner packaging or sterile barrier).No other devices in the same box/shipping container were damaged.There was no transfusion required as a result of this issue.

Manufacturer Narrative

Conclusion: the complaint is confirmed for disconnected tubing.Visual inspection of the retuned device showed that the tubing was separated from the device.After evaluation the cause of this complaint is possibly related to the design of the purge line.Since this event could not be confirmed by the manufacturing process photographic evidence, a notification for the present manufacturing personnel was performed to avoid future occurrences and an action was opened to add silicon band on connections in the purge line to ensure a strong connection.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 modes were reviewed and showed no trends warranting escalation related to this occurrence.Assessment against the medtronic risk management file process failure mode effects and criticality analysis (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 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: MEDTRONIC 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: 16193553
• MDR Text Key: 308940204
• Report Number: 9612164-2023-00250
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00643169717985
• UDI-Public: 00643169717985
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171979
• 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
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BB8B89R3
• Device Catalogue Number: BB8B89R3
• Device Lot Number: 224582572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2022
• 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