MAUDE Adverse Event Report: LIVANOVA USA, INC. SORIN; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number 627237501

Device Problems Gas/Air Leak (2946); Noise, Audible (3273)

Patient Problems Bradycardia (1751); Death (1802); Low Blood Pressure/ Hypotension (1914)

Event Date 09/04/2017

Event Type  Death  

Event Description

When applying the stopcock/luer lock of the inlet line of the right ventricular assist device (rvad) to inflow cannula, there was an audible cracking sound and air was being entrained creating and airlock which stopped the rvad from circulating.The patient quickly became bradycardic and hypotensive.We were unsuccessful in removing the air from the circuit, requiring a new rvad circuit with oxygenator.Despite now being able to flow nearly 3l/min, patient's pulmonary artery (pa) pressures equaled systemic.On transesophageal echocardiogram (tee), her right ventricle (rv) was severely dilated and she was converted to venous arterial extracorporeal membrane oxygenation (va ecmo) and right femoral artery was accessed using a 17fr cannula over the wire.The pulmonary artery (pa) and right atrium (ra) cannula were y-d together as the outflow cannula.Next, the right superficial femoral artery (sfa) was accessed with a micropuncture kit using ultrasound guidance, and a 7fr cannula was inserted over the wire and connected to the inflow cannula for distal perfusion.The doctor removed the device.

• Brand Name: SORIN
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC.; 14401 west 65th way; arvada CO 80004 3503
• MDR Report Key: 8252696
• MDR Text Key: 133221582
• Report Number: 8252696
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 627237501
• Device Lot Number: 1717700066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 25550 DA