MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN S5 SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 48-40-00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sudden Cardiac Death (2510)

Event Date 11/25/2016

Event Type  Death  

Manufacturer Narrative

Patient identifier not provided.Sorin group (b)(4) manufactures the s5 console.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Additional information regarding the cardiac surgery performed on the deceased patient was released by the perfusionist.The first cec (extra corporeal circulation) took 1 hour and 44 minutes to complete, during which time 2 valves were replaced.After completion of the first cec, an ultrasound was performed which showed damage to the heart.A second cec was started to repair the patient's heart, which took 3 hours and 20 minutes.At the end of the second cec, the venous cannula was removed and an ultrasound examination showed intra ventricle circulation and decreasing pressure.A venous cannula was reinserted and a third cec was initiated.During the third cec, the arterial pump displayed a level alarm.The perfusionist stated that the pump did not stop.After the alarm, hemolytic foam was observed in the area of the arterial cannula, but not in the oxygenator or tubing.The arterial pump was manually stopped and a massive amount of bubbles were noted at the patient.The arterial line was clamped and the cardiac surgery team decided to change the entire s5 system and the oxygenator, as they believed the oxygenator was responsible for the hemolytic foam.The change-out took 5 minutes.The pressure of the patient dropped very low and the surgery continued with the new s5 system for 10 minutes before the patient was declared deceased.A sorin group field service representative was dispatched to the facility to investigate.The service representative was unable to identify any issues related to the involved equipment.All devices were tested and were found to be working according to specification.A serial readout of the arterial pump was performed and returned to sorin group deutschland for evaluation.A technical safety inspection of the s5 system was successfully performed and the unit was returned to service.Analysis of the serial readout revealed a pump stop due to the level alarm during the third cec.The perfusionist stated that the pump did not stop, but rather a manual decrease of flow of the arterial pump was performed.This is also documented in the readout.Through follow-up communication with the perfusionist, the service representative was informed that the reservoir was never empty and the arterial tubing line going from his position to the patient was clean of bubbles and/or hemolytic foam.According to the instructions for use (ifu) for the sorin s5 system, a proper s5 configuration shall include the use of a bubble sensor.A pressure transducer and arterial clamp are also highly recommended.The cardiac surgery team operating the equipment did not use any type of bubble monitoring system.A review of the dhrs for the involved equipment did not identify any deviations or non-conformities relevant to the reported issue.The investigation performed by sorin group (b)(4) was unable to identify any indication that the equipment caused or contributed to the reported event.Sorin group (b)(4) will continue to monitor the market for trends related to this type of issue.Evaluated on-site by sorin service rep.

Event Description

Sorin group (b)(4) received a report that a patient died after a massive gaseous embolism (foam) was observed in the arterial cannulae during a procedure.The surgery was originally intended to replace the aortic valve after the patient suffered a valvular heart malfunction.After the first intervention, the surgeon decided to continue the operation with a mitral valve repair.The condition of the patient was reported as being extremely critical even before starting the second procedure.During the operation, the surgeon observed the presence of hemolytic foam mixed together with bubbles in the aortic cannulae.The patient was officially declared dead due to a cardiac arrest 15 minutes later.

• Brand Name: SORIN S5 SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6197133
• MDR Text Key: 63048455
• Report Number: 9611109-2016-00903
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/29/2016

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
• Device Operator: Health Professional
• Device Model Number: 48-40-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Weight: 65