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 No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2019

Event Type  malfunction  

Manufacturer Narrative

There was no known patient involvement.(b)(6).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).A review of the dhr could not identify any deviations or nonconformities relevant to the issue.Corrective actions are in progress for this 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

Livanova (b)(4) received a report, that a heater-cooler system 3t was found to be contaminated with mycobacterium chimaera.Hospital performed lab test, which confirms the contamination with mycobacterium chimaera.The report has been provided to livanova (b)(4).There is no known patient involvement.

Manufacturer Narrative

Through follow up communication for complaint # (b)(4).Livanova deutschland has been informed that the customer used reusable heating blankets.It is likely that those pads are source of contamination, therefore the customer swap them with disposable ones.The information received under complaint # (b)(4) is likely valid also for this case.

Event Description

See initial report.

Manufacturer Narrative

H.10: through follow-up communication with the customer livanova deutschland learned that the device was cleaned regularly per the instruction for use and that it was placed inside the operation theatre with the fan positioned opposite to the patient, at an estimated distance between the surgery field and the device of two (2) meters.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; lindberghstr. 25; munich
• MDR Report Key: 8910125
• MDR Text Key: 175852821
• Report Number: 9611109-2019-00643
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 04033817901099
• UDI-Public: 010403381790109911190123
• 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: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• 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
• Date Manufacturer Received: 11/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1