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

Model Number 16-02-85

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

Partial information about the patient has been provided.The date of the event will be provided in a supplemental report if made available.Livanova deutschland 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)(4).Livanova deutschland initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a medwatch #(b)(4) stating that a (b)(6) male patient had coronary bypass earlier this year in which the livanova 3t heater-cooler device was utilized during the procedure.Patient presented to clinic a few months ago for evaluation of sternal wound and returned to surgery.Cultures from sternal wound tested positive with mycobacterium chimaera.In the report is stated that the date of event was (b)(6) 2019.

Manufacturer Narrative

H.10: through follow-up communication livanova learned that the date of the surgery was (b)(6) 2019.The information has been added to the dedicated section b.3.Moreover, livanova learned that the patient presented to the hospital on (b)(6) 2019 with incisional erythema.On (b)(6) 2019 the patient was confirmed to be infected with m.Avium intracellulare complex and m.Chimaera was identified.The patient was discharged the same day.He cannot start medical therapy until an alternative for methadone is found (drug interactions).Through further follow-up communication with the chief perfusionist livanova learned that the water in the heater-cooler systems 3t in use is changed every day and they are stored dry.This is not in alignment with current instruction for use however reportedly the devices are very clean and there is no sign of biofilm.The devices are located inside the operating theatre during use.We are currently waiting to know the result of microbial sampling performed at customer site.Reportedly the tests are still in progress.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

H.10: two (2) over five (5) devices which were in use at the hospital resulted to be contaminated.Only one serial number has been provided ( (b)(6) ) and a follow up report for the cases associated to this specific device has been filed.The second serial number remains unknown as well as the type of contamination.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 9316401
• MDR Text Key: 174853377
• Report Number: 9611109-2019-00896
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K052601
• 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: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• 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 the Report Sent to FDA?: No
• Date Manufacturer Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1