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

Model Number	HY11P20R4
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that prior to use of this custom tubing pack, the customer reported that the quick connect exiting the oxygenator was leaking.Clinician removed quick connection, checked integrity of o-ring and re-connected the hoping to seal the leak, it did not work.Clinician replaced the quick connect with a 1/4 x 1/4 straight connector for the case and kept a close eye on the other 2 quick connects in circuit for the remainder of the case.And neither leaked. the device was replaced to complete the procedure.There was no patient involvement so no adverse effect occurred.Additional information: the same leak did not appear in multiple packs.The leak occurred during de-airing/priming of the system.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows evidence of damage to a couple sides of the male connector, (see photos).Unit appears to have been primed.Note: video provided by the customer shows evidence of a leak.Performance analysis: pressure integrity testing was performed at 0.5 l/pm with 23 psi, (1189 mmhg) of back pressure for 10 minutes.During the pressure integrity testing there was a leak observed from the device, (see video).Conclusion: reason for return was confirmed.Unit will be held in brooklyn park.Conclusion: complaint is confirmed for leaks.Visual inspection shows evidence of damage to a couple sides of the male connector.Manufacturing process was reviewed and was not found abnormalities that could lead the defect.After evaluation the cause of this complaint could not be determined.However, it was identified this defect could possibly be attributed to the component damaged from supplier.Currently there is a pr investigation on-going through pr 560022 to identify and address the root cause.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.Complaints received from august 2021 through november 2021 for the same failure mode were reviewed and showed no trends warranting escalation related to this occurrence.Assessment against the medtronic risk management file pfmeca document (fmea0002-06) indicates that the current risk zone does not exceed the risk zone predicted in the product pfmeca; therefore, no capa will be initiated at this time.There were no adverse patient effects as a result of this incidence.Review of the complaint file indicates sufficient information was provided for completion of this investigation.Medtronic will continue to monitor for future occurrences and trends per trend analysis procedure (sop297).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: 17170003
• Report Number: 9612164-2023-02742
• Device Sequence Number: 7066844
• Product Code: DWE
• UDI-Device Identifier: 00763000574352
• UDI-Public: 00763000574352
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/21/2023

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 Model Number: HY11P20R4
• Device Catalogue Number: HY11P20R4
• Device Lot Number: 222918301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2021
• 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