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

Model Number 43-40-00

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

Patient Problem Death (1802)

Event Date 04/20/2017

Event Type  Death  

Manufacturer Narrative

The date of the patient death was not provided.This information will be provided in a supplemental report if made available.(b)(4) manufactures the s3 system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of (b)(4).(b)(4) became aware of the incident when a police officer investigating the event contacted the company for information related to the operation of the s3 system.No indication was given at that time that a device malfunction had occurred.Through a review of the information provided by the police regarding the incident, the event was likely related to a user negligence.During follow-up communication, the customer informed (b)(4) that they are not allowed to comment on the incident due to the ongoing criminal investigation.No further information will be provided by the customer.Therefore, no further investigation is possible.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

(b)(4) received a report that the s3 console was not connected correctly by the user during a procedure, which led to the death of a patient.

• Brand Name: S3 CONSOLE
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• 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: 6595974
• MDR Text Key: 76123385
• Report Number: 9611109-2017-00392
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K950990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 43-40-00
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2001
• 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