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 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

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.There was no known patient involvement.

Event Description

See initial.

Manufacturer Narrative

Through follow-up communication with the customer, livanova deutschland learned that the device was cleaned according to the instruction for use and placed inside the operation theatre.The device was positioned two meters away from the patient table with the fan directed in the opposite direction of the patient.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

Through follow up communication, livanova deutschland learned that the hospital used multiple-use heating blankets until march 2019.Those blankets are not included in the heater-cooler system 3t water circuit disinfection, thus are potential source for external contamination.The hospital agreed on changing the approach and use the single use heating blankets.

Event Description

See initial.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 8205888
• MDR Text Key: 131776188
• Report Number: 9611109-2018-01449
• 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: 06/21/2019

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 Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/31/2018
• Supplement Dates Manufacturer Received: 01/14/2019; 05/24/2019
• Supplement Dates FDA Received: 02/12/2019; 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1