MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16-02-82

Device Problem Microbial Contamination of Device (2303)

Patient Problem Death (1802)

Event Date 09/21/2015

Event Type  Death  

Manufacturer Narrative

Further details on patient information were not provided.Serial number is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Livanova (b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is (b)(4).Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Through follow up communication, livanova (b)(4) learned that ahs is unable to confirm the exact devices used at the time of the surgery due to a lack of device tracking in the or when the adverse event occurred.Ahs replaced contaminated sorin 3t heater cooler unit devices with new devices in 2017.The devices were placed inside of the operation theater during use with the fan of the device positioned away from the patient at an unknown distance between the surgery field and the device.Furthermore, livanova (b)(4) learned that ahs did and continues to follow all livanova cleaning and disinfection ifu and the action taken on this event was treatment of injured party.Growth tests to confirm patients infection were performed.Corrective actions are in progress for this issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.

Event Description

Livanova (b)(4) received a report on a deceased male patient, who was operated on of (b)(6) 2015 positive tested positive on mycobacterium chimaera on (b)(6) 2018.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, 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: barbara galasso ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 8670147
• MDR Text Key: 147042601
• Report Number: 9611109-2019-00411
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K052601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-82
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Death