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 12/03/2019

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) has been informed that the device was cleaned regularly per the instructions for use and that it is placed inside the operating theatre at an estimated distance of 2 meters from the surgery field with the fan directed opposite to the patient.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 environmental mycobacterium.There is no known patient involvement.

Manufacturer Narrative

H.10: on july 7, 2020, through follow-up communication under another complaint from the same hospital livanova learned that the device was cleaned and maintained as per the instruction for use and that it was placed inside the operating theatre during use at an estimated distance of two (2) meters with the fan pointing away from patient outisde central airflow zone of theatre.Furthermore, livanova learned that the tanks are emptied during period of non-use(i.E.Week ends).However, the hospital has one device left full of water for emergencies while the other two devices remain empty.For the emergency unit the peroxide (h2o2) level is not checked on a daily basis as prescribed by the ifu (not checked during week ends).Reportedly, for this specific device the h2o2 level was adequate when checked on monday.In addition, livanova was informed that the hospital is user of reusable blankets and it is reasonable to assume that the hospital was user of reusable blankets also back in 2019.It can't be excluded that the usage of reusable blankets may have caused / contributed to the reported contamination.

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: 9530671
• MDR Text Key: 196755481
• Report Number: 9611109-2019-01018
• 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: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• 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: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1