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

Model Number HY7J97R16

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2023

Event Type  malfunction  

Manufacturer Narrative

Visual inspection shows no outward signs of damage.Pressure integrity testing was performed at 0.5 l/pm with 15 psi, (750 mmhg) of backpressure for 10 min.During the pressure integrity test there was a leak observed at one of the swivel luer fittings.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 Description

Medtronic received information that prior to use of custom pack, it was reported that the bridge in the pack started leaking during priming.The device was replaced.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that the leak occurred where the tubing attaches to the connector.It appeared to the end user as if there was not a good seal between the tubing and the connector.There was no visible air in system/tubing.The exact location of the leak was in the purge line in the circuit.There was no damage observed to the device or packaging.

Manufacturer Narrative

Conclusion: the complaint is confirmed for leaking component.A product analysis was performed, and the reported failure mode was replicated.The raw material lots were inspected, and no abnormalities were found.The supplier was notified of the event to facilitate review of the manufacturing process and document results.The assembly configuration was shown to be performed as required per specification for the ¿c¿ for connection from the luer.However, the manufacturing process and equipment parameters were reviewed, and it was identified that all controls were in place to prevent this non-conformance during assembly.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.Assessment against the medtronic risk management file indicated that the current risk zone does not exceed the risk zone predicted in the product process failure mode effects and criticality analysis (pfmeca).There were no adverse patient effects because of this incidence.Medtronic will continue to monitor for future occurrences and trends.Correction d3 (mfr name) and d3.6 (postal code): these fields have been updated.Correction h6.1 (device codes (fdd/annex a)) and h 6.3 (eval code result (fdr/annex c)): these codes have been updated.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 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17501078
• MDR Text Key: 321325140
• Report Number: 9617601-2023-00172
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00763000834432
• UDI-Public: 00763000834432
• 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: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HY7J97R16
• Device Catalogue Number: HY7J97R16
• Device Lot Number: 226045931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2023
• 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