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

Model Number 6031

Device Problem Break (1069)

Patient Problem Exsanguination (1841)

Event Date 08/25/2019

Event Type  Injury  

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 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.

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
• Type of Device: 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9334255
• MDR Text Key: 166738579
• Report Number: 9612164-2019-04774
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 40613994352864
• UDI-Public: 40613994352864
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K800178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2019
• Date Device Manufactured: 09/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 60