MAUDE Adverse Event Report: MEDTRONIC MEXICO 3/8 X 3/8 X 3/8 Y; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number	6031
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	01/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows evidence of some damage/cut in one of the connectors.Pressure integrity testing was performed at 3 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 damaged connection and one of the other two.The tubing was removed from the damaged connection and it was not a crack, it is a cut along the length of the connection.Reason for return was confirmed.Outcome attributed to adverse event - other (micro air embolism with no reported treatment).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during use of a 6031 intersept connector, the customer reported that there was a crack in the connector, causing air to be entrained in the ecmo circuit.The air was visibly entraining through the connector, and the cardiohelp bubble detector alarmed.The connector was being used to add an additional limb to ecmo circuit.They think the patient received micro air embolism.The patient subsequently expired.It was reported that the death was multifactorial but the customer doesn't attribute it to this incident.Additional information received reported that the customer did not notice a crack in the device before use.

• Brand Name: 3/8 X 3/8 X 3/8 Y
• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 13449600
• Report Number: 9612164-2022-00477
• Device Sequence Number: 17502045
• Product Code: DWE
• UDI-Device Identifier: 40613994352864
• UDI-Public: 40613994352864
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K800178
• 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): 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/21/2023
• Device Model Number: 6031
• Device Catalogue Number: 6031
• Device Lot Number: 223119236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown