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

Model Number 16-02-80

Device Problem Microbial Contamination of Device (2303)

Patient Problem Endocarditis (1834)

Event Date 06/21/2019

Event Type  Injury  

Manufacturer Narrative

Partial information about the patient has been provided.Through follow-up communication with the customer livanova (b)(4) learned that the patient year of birth is (b)(6).The serial number of the device used during the surgery 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.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 with the customer livanova (b)(4) learned that in (b)(6) 2018, before endocarditis diagnosis, the patient underwent cardial surgery with culture-negative valve.A spondylodiscitis m chimaera culture resulted positive on (b)(6) 2019.The patient is under quadruple antibiotic therapy since the (b)(6) 2019.A pcr (polymerase chain reaction) on the heart valve in june, 2019 showed mycobacterium chimaera endocarditis diagnosis.Through follow-up communication with the customer livanova (b)(4) learned that the possibly involved serial numbers are the followings: (b)(4) (all devices used by the hospital in 2014).Through further follow-up communication livanova (b)(4) learned that the devices were disinfected each 3 months using maranon and that the devices were placed inside the operating theatre at that time of the surgery.The devices were placed in parallel with the patient at an estimated distance from the surgery field of at least 2 meters with the fan in parallel with the patient.Device not returned.

Event Description

Livanova (b)(4) received a report that a patient undergone a mitral valve annuloplasty surgery in 2014, developed an endocarditis due to mycobacterium chimaera.The heater-cooler system 3t is the suspected source of the contamination.

Manufacturer Narrative

H.10: the laboratory report confirming the contamination of the suspected devices has been provided.At the time of the surgery ((b)(6)) six units were used.The first cultures were performed in (b)(6) and 4 units tested positive for mycobacterium chimaera.The 2 other units tested negative at the first cloture in (b)(6), turned positive later on.A review of the dhr on all six devices did not identify any deviations or non-conformities relevant to the reported issue.Investigation is still ongoing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

Through further follow-up communication livanova deutschland learned that the 2 other units tested negative at the first culture in 2015 were (b)(4) and (b)(4).Thus, the possibly involved serial numbers are: (b)(4).

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 8892367
• MDR Text Key: 154333397
• Report Number: 9611109-2019-00630
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-80
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: 08/22/2019; 10/17/2019
• Supplement Dates FDA Received: 09/19/2019; 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Other