MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN S3 CONSOLE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 43-50-00

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

Patient Problems Air Embolism (1697); Coma (2417)

Event Date 02/10/2016

Event Type  Injury  

Manufacturer Narrative

Patient identifier was not provided.Sorin group (b)(4) manufactures the sorin s3 console.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that air was delivered to the patient while connecting the sorin s3 console and medtronic-manufactured centrifugal pump disposables to the patient.The patient is comatose.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.Customer wishes to retain the unit.

Event Description

Sorin group (b)(4) received a report that air was delivered to the patient while connecting the sorin s3 console and medtronic-manufactured centrifugal pump to the patient.The patient is comatose.

Manufacturer Narrative

Livanova (b)(4) manufactures the sorin s3 console.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).Livanova (b)(4) learned that the surgeon reportedly clamped the line and used a suction pump to get the air out of the patient.The medtronic tubing set (cec kit trmp medtronic ref (b)(4); drenaggio per aspirazione intracardiaco ref (b)(4) medtronic; kit mitralico medtronic ref (b)(4)) was scrapped by the customer.Initially, the involved s3 console was quarantined and further investigation could not be performed.A service history check over the last 3 years did not reveal any problems and confirmed that the s3 was working according specification.When the device was released, a livanova field service representative was dispatched to the facility to investigate.The service representative checked the system and performed preventive maintenance.The system was found to be working according to specification.Further testing found no further issues and the system was returned to service.As the customer scrapped the medtronic tubing circuit, used a medtronic master pump, and the issue could not be reproduced on the s3, a root cause could not be determined and corrective actions were not identified.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Evaluated on site by livanova rep.

• Brand Name: SORIN S3 CONSOLE
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich,
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 5499489
• MDR Text Key: 40299120
• Report Number: 9611109-2016-00177
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K950990
• 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,Followup
• Report Date: 09/06/2017

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: 43-50-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2016
• Initial Date FDA Received: 03/14/2016
• Supplement Dates Manufacturer Received: 08/10/2017
• Supplement Dates FDA Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/1998
• 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): Other
• Patient Age: 52 YR
• Patient Weight: 80