MAUDE Adverse Event Report: SORIN GROUP USA, INC. LIVANOVA; RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Model Number 4000 RESERVOIR

Device Problems Device Dislodged or Dislocated (2923); Pressure Problem (3012)

Patient Problems Cardiac Arrest (1762); Death (1802); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477); Abdominal Distention (2601)

Event Date 09/03/2016

Event Type  malfunction  

Event Description

In early (b)(6) 2016, a (b)(6) male, presented for aortic and mitral valve replacement with left atrial appendage device occlusion.The patient was placed on bypass and valves inserted with atrial appendage ligated.There was noted to be some bleeding and the patient was put back on bypass to control the bleeding.There was substantial bleeding coming from behind the heart more on the right hand side.There was also some epicardial surface bleeding several centimeters away from the atrial appendage felt to possibly be due to atriclip applicator.This area was buttressed and made hemostatic.There was still noted to be substantial bleeding coming from the right pulmonary vein.The patient was put back on bypass and the left atriotomy area was pledgeted.Again the patient was weaned off bypass and appeared much more hemostatic.Venous lines were removed when it was felt there was an air free situation.Only the aortic cannula and aortic root vent were in place and there was no real bleeding.At this time the patient had a dip in his blood pressure and it was noticed air frothing through the epicardial surface of the heart and heart distention.Cardiopulmonary resuscitation was started with open chest message.Simultaneously a loud popping noise was heard and it was realized for some undetermined reason the integrated venous reservoir/cardiotomy due to over pressurization of the cardiotomy compartment developed so much pressure it caused it to pop a cap on one of the ports on the top of the reservoir sending blood as high as the ceiling of the operating room.It should be noted that the venous reservoir low-level sensor was on while on bypass as well as an arterial line air bubble detector on while the pump was primed and in use.A new pump and filter were set up and reprimed.A single stage venous cannula was placed in the right atrium and the patient went back on full flow to de-air the heart.It was noted the patient had very low cerebral oximetry after another hour of cardiac arrest.Ultimately an iabp and ecmo were placed and the patient taken to icu at approximately 11:30 where he expired the following morning twelve hours later.

• Brand Name: LIVANOVA
• Type of Device: RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 west 65th way; arvada CO 80004
• MDR Report Key: 6339171
• MDR Text Key: 67704668
• Report Number: 6339171
• Device Sequence Number: 1
• Product Code: DTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2016,10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 4000 RESERVOIR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CARDIAC DRUGS; NO
• Patient Age: 73 YR
• Patient Weight: 72