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 Type  malfunction  

Manufacturer Narrative

There was no known patient involvement.The heater-cooler 16-02-80 is not distributed in the usa and it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).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).Within the report it was stated that the device was cleaned according the instruction for use.Livanova 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 report vk_20201119_13 from (b)(6) that a heater-cooler system 3t device was found to be contaminated with acid-resistant bacilli.There is no known patient involvement.

Manufacturer Narrative

H10: through follow-up communication livanova confirmed that the device was cleaned regularly per the instruction for use and that it was placed outside the operating theater during use.

Event Description

See initial report.

Event Description

See initial report.

Manufacturer Narrative

H.10: no further information is available on this specific case.Through follow-up communication performed in 2019 on previous contamination complaint for the same unit, livanova learned that the device was cleaned accordingly to the instruction for use and that it was placed outside the operating theatre.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 11147473
• MDR Text Key: 226043463
• Report Number: 9611109-2021-00009
• 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: other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• 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: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1