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	Break (1069)
Health Effect - Clinical Code	Exsanguination (1841)
Date of Event	08/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event date entered is month and year valid.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that about 20:00 hrs during the extra corporeal membrane oxygenation (ecmo) procedure, the customer reported leaking from around the y-connector that connected the lv vent to the venous drainage line on the ecmo circuit.The customer was concerned that the leak was either due to a loose connection or that one of the lines was fractured.Following notification to the perfusionist, md and surgeon, they intended to fix the issue using a zip tie and bone wax.However, around 21:00 hrs, the y-connector the broke and the patient began to exsanguinate.Flows were lost and cpr was initiated.They then clamped the ecmo cannula, mass transfusion protocol was initiated, patient was intubated and a line was placed.They were able to replace the y-connector and re-establish flow.
Additional Manufacturer Narrative
Visual analysis: visual inspection shows one of the 3/8 inch tubing connections has broken off.Device was cleaned using a 10% bleach solution.Conclusion; based on the investigation results it can be concluded that there is not enough evidence to say that the damage was cause during the manufacturing process since the handling of the connector performed during the inspection and packaging does not required to apply force that could damage the ports of the connector.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 9334255
• Report Number: 9612164-2019-04774
• Device Sequence Number: 11224906
• Product Code: DWE
• UDI-Device Identifier: 40613994352864
• UDI-Public: 40613994352864
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K800178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/19/2020
• Device Model Number: 6031
• Device Catalogue Number: 6031
• Device Lot Number: 216211872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 01/06/2020
• 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: Required Intervention
• Patient Age: 40 YR
• Patient Weight: 60