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

Model Number 16-02-85

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

Patient Problems Bacterial Infection (1735); Weight Changes (2607)

Event Date 04/18/2017

Event Type  Injury  

Manufacturer Narrative

Livanova (b)(4) implemented a field safety notice for disinfection and cleaning of sorin heater-cooler devices.The z number is z-2076/2081-2015.Livanova (b)(4) manufactures the heater-cooler system 3t.The event occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).Through follow-up communication with the customer, livanova (b)(4) learned that the patient is currently still on antibiotic therapy.The customer provided the results from (b)(6), which found that the patient infection is not the same clonal as any of the strains that have been linked to livanova devices.The customer reported that disinfection is performed every two weeks with sterile tubing replacement and a water change.On the alternate weeks, the water is replaced with sterile water and hydrogen peroxide is added according to the instructions for use (ifu).The customer stated that monthly culturing is conducted and the involved unit tested positive for contamination after 6 weeks of incubation.The culture identified 20 opaque white colonies, but no organisms were identified.The sample which tested positive was taken on (b)(6) 2017, and all previous samples were negative.The devices are placed within the operating room during use.However, the customer reported that the involved unit was last used on (b)(6) 2017 and has been retired.During additional communication with the customer, it was reported mycobacterium chimaera contamination has been confirmed in the reported serial number.Genome sequencing is still being conducted in order to compare the strain to known isolates linked to heater-cooler-associated outbreaks as well as the isolate recovered from the patient.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The investigation is on-going.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 (b)(4) stating that a patient with a history of idiopathic cardiomyopathy underwent a heart transplant on (b)(6) 2012.The report indicated that the patient failed to thrive and experienced weight loss post-procedure.The patient was found to have rul tree in bud nodules and an acid-fast bacillus culture tested positive for mycobacterium chimaera on (b)(6) 2017.The patient was started on therapy with azithromycin, ethambutol and rifabutin on (b)(6) 2017.The customer reported that they are still investigating whether this is related to the heater-cooler system 3t.The isolate was sent to (b)(6) as part of the investigation.

Manufacturer Narrative

The lab test result confirming the presence of mycobacterium chimaera was provided on (b)(6) 2017.Despite several attempts requesting the results of the genome sequencing over a three month period these have not been provided until this date.Livanova (b)(4) has initiated corrective action for this type of issue.

Manufacturer Narrative

(b)(6).Livanova (b)(4) received a report confirming that the patient strain does not match the heater-cooler system 3t strain which was used during that 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: 6620631
• MDR Text Key: 76941780
• Report Number: 9611109-2017-00382
• 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: Risk Manager
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2009
• 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): Life Threatening; Other
• Patient Age: 68 YR
• Patient Weight: 84