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 Problems Bacterial Infection (1735); Endocarditis (1834)

Event Date 09/10/2014

Event Type  Injury  

Manufacturer Narrative

Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).There is no known device malfunction and the details of the involved unit are unknown.However, through follow-up communication with the customer regarding different complaints, livanova (b)(4) learned that several of the heater-cooler devices at the facility have been removed from service.The customer stated that the cleaning protocols have been followed and the units have been used within the or during procedures.The contact stated that the units have not and will not be tested for contamination.On (b)(6) 2016, livanova (b)(4) received a loaner request from the facility for the involved device, stating that the unit has been sequestered in compliance with governing entities due to non-tuberculous mycobacteria (ntm) contamination.Through additional follow-up communication with the customer, livanova (b)(4) was informed that no further information will be provided regarding this type of issue.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.Device not returned.

Event Description

On (b)(6) 2017, livanova (b)(4) received a user medwatch report (mw5069099) which indicates that a patient who underwent an aortic valve replacement in 2014 developed discitis/osteomyelitis of t11/12 and prosthesis valve endocarditis.A biopsy confirmed mycobacterium chimaera in 2017.A heater-cooler system 3t was used during the 2014 procedure.

Manufacturer Narrative

The manufacturer narrative in the initial report, submitted june 1, 2017, contained a typo.The report indicated that the report was related to "non-tuberculous mycabacteria," but the correct term is non-tuberculous mycobacterium.

• 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: 6606909
• MDR Text Key: 76480342
• Report Number: 9611109-2017-00368
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• 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: 05/02/2017
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other