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

Model Number 16-02-85

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Fatigue (1849); Pain (1994); Blurred Vision (2137); Chills (2191); Sweating (2444)

Event Date 01/10/2017

Event Type  malfunction  

Manufacturer Narrative

Patient identifier was not provided.Patient weight was not provided.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601).Livanova (b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Through follow-up communication livanova (b)(4) learned that the heater-cooler system 3t was not tested if it is contaminated.It was reported that the device was placed inside the operation theatre, far away and with the fan positioned away from the operation table.Further samples were taken from the patient but it was not possible to confirm the infection.A review of the dhr did not identify any deviations or non-conformities relevant to the reported 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

On (b)(6) 2017, livanova (b)(4) received a user medwatch report ((b)(4)) which indicates that a patient is potentially infected with mycobacterium chimaera.The patient underwent a coronary artery bypass grafting on (b)(6) 2017 and a heater-cooler system 3t was used during the procedure.In (b)(6) 2017 the patient developed night sweats, fatique, back pain, chills and blurry vision.

Manufacturer Narrative

Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(4).Through follow-up communication livanova (b)(4) learned that the patient was discharged pending of additional cultures, afb+.Additional samples were taken.A review of the shr did not identify any deviations or non-conformities relevant to the reported issue.Since the patient has decided to proceed with an attorney, the hospital will have no more communication with the patient.No further investigation is therefore possible.In the event of receipt of new information, a supplemental report will be provided.Corrective actions are in progress for this issue.Device not returned.

• 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: 7063147
• MDR Text Key: 93609202
• Report Number: 9611109-2017-00925
• 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: Notification
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2012
• 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): Hospitalization; Life Threatening; Other
• Patient Age: 54 YR