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

Model Number 16-02-82

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

Patient Problem Death (1802)

Event Date 11/02/2015

Event Type  Death  

Manufacturer Narrative

(b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is being filed on behalf of (b)(4).During follow-up communication with the customer for a different complaint, the contact stated that they are unable to provide further information regarding this type of issue due to on-going litigation.Therefore, no further investigation is possible.It is unknown if the involved device was found to be contaminated.

Event Description

On april 24, 2017, (b)(4) received a user medwatch report (mw5068979) stating that a patient who underwent a bioprosthetic aortic valve replacement and root repair with autologous pericardium in 2015 developed fatigue, dry cough, weight loss, fever and chills in 2016.The patient was admitted to the hospital in 2017 and a live biopsy was performed.The culture from the patient identified a mycobacterium chimaera infection.The patient elected to cease treatment and expired on (b)(6) 2017.The user report stated that a heater-cooler system 3t was utilized during the 2015 procedure.

• 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: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6586589
• MDR Text Key: 75814259
• Report Number: 9611109-2017-00351
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• 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
• Date Manufacturer Received: 04/24/2017
• 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; Hospitalization