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

Model Number 16-02-80

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/12/2019

Event Type  malfunction  

Manufacturer Narrative

There was no known patient involvement.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).Livanova (b)(4) initiated an investigation.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.

Event Description

Livanova (b)(4) received a report that a heater-cooler system 3t device was found to be contaminated with mycobacterium chelonae.There was no known patient involvement.

Event Description

See initial report.

Manufacturer Narrative

Through follow-up communication livanova deutschland learned that the device was cleaned regularly per the instruction for use and that it was placed inside the operating theatre during using with the fan opposite to the patient at an estimated distance between the surgery field and the device of about 3 meters.If any additional information pertinent to the reported event is received, it will be provided in a supplemental 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: 9361047
• MDR Text Key: 196154054
• Report Number: 9611109-2019-00911
• 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
• Report Date: 12/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-80
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/26/2019
• Initial Date FDA Received: 11/22/2019
• Supplement Dates Manufacturer Received: 11/26/2019
• Supplement Dates FDA Received: 12/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1