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

Model Number	HY7W39R28
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of this custom tubing pack a leak was observed on the positive side of their arterial roller pump head where there is a connector.The connection is tie banded, but after 4 hours on bypass with pressures around 300mmhg it started to slowly drip.The customer stated that the patient lost a minimal amount of blood, maybe 5ml.The custom tubing pack was used to complete the procedure.Patient impact was requested but it was reported as unknown.The customer has decided to change back to taper flex tubing to prevent this from happening again.Additional information confirms that there was no visible air in the system/ tubing.
Additional Manufacturer Narrative
Conclusion: 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.During the manufacturing of the order, the involved line was manufactured at operation 80.The assembly consists to connect 3/8 tubing to 3/8 connector port.All the pieces were reviewed and the defect or any anomalies cannot be detected.Dhr did not show anomalies on their registers.By edhr we can confirm the correct tubing was used.Q.C.Inspection form was reviewed, and no anomalies were found.With the current information and without the device for analysis a definitive root cause could not be determined; we cannot confirm if the device contains any damage or anomalies generated on supplier/manufacturing or transportation process.Trends for issues with this product are reviewed monthly.This regulatory report is being submitted as part of a retrospective review and remediation per d00953163 as part of a capa action.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.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 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: 17098097
• Report Number: 9612164-2023-02501
• Device Sequence Number: 11239633
• Product Code: DWE
• UDI-Device Identifier: 00763000541101
• UDI-Public: 00763000541101
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171979
• 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
• Report Date (Section B): 06/09/2023

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: 06/02/2023
• Device Model Number: HY7W39R28
• Device Catalogue Number: HY7W39R28
• Device Lot Number: 222581338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2021
• 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