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

Model Number	HY7V82R20
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: visual inspection showed the device has blood on one side of the membrane.During the cleaning process there were no leaks observed.The device was connected to a pressure gage.A syringe filled with di water was connected to the opposite end and then was engaged so there was approximately 400 mmhg displayed.After 5 minutes there was no leaked noted.Reason for return was not confirmed.Conclusion: the complaint was not confirmed for leaking pressure dome.Analysis found that the product performs as expected and there is no visual damage.After evaluation the cause of this complaint could not be determined.The device history record was not reviewed as returned product analysis found no evidence of manufacturing issues with the returned device.Assessment against the medtronic risk management file 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 as a result of this incidence.Medtronic will continue to monitor for future occurrences and trends per trend analysis procedure.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.
Event or Problem Description
Medtronic received information that prior to use of a custom tubing pack, it was reported that the pressure dome leaked and blood filled the transducer.The device was replaced.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that leak did not occur in multiple packs.There was no visible air in the system/ tubing.The diaphragm seems to have separated because the blood ended up on the side that was supposed to only have air.There was no damage to the device and packaging medtronic received additional information that the circuit was primed with plasmalyte, and then went on to pump which then mixed with the blood.Customer went to read the pressure transducer and noticed the blood was in the dome and customer had not turned the stopcock to read it yet.There was no adverse effects, customer just replaced the pressure line and there was no additional blood loss or external leaks.

• 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: 16938338
• Report Number: 9612164-2023-02045
• Device Sequence Number: 17646597
• Product Code: DWE
• UDI-Device Identifier: 00763000316976
• UDI-Public: 00763000316976
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/16/2023

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: 10/26/2024
• Device Model Number: HY7V82R20
• Device Catalogue Number: HY7V82R20
• Device Lot Number: 225775452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• 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