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 06/12/2020

Event Type  malfunction  

Manufacturer Narrative

There was no 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).Through follow-up communication livanova learned that the hydrogen peroxide (h2o2) level may not have been tested daily during the last few weeks/months.Reportedly, it is usually tested correctly, unfortunately during covid-19 emergency they have moved theatres and didn¿t have access to their usual theatre and equipment.Through further follow up communication livanova learned that the device was stored drained.It is still unclear if the device was in use or not and if water quality monitoring was conducted according to the ifu.The investigation is still on going.

Event Description

Livanova (b)(4) received a report that a heater-cooler system 3t device was found to be contaminated with mycobacterium chimaera.The laboratory report confirming the reported contamination has been provided to livanova.There is no known patient involvement.

Manufacturer Narrative

(b)(4) received a report of a heater-cooler 3t system which was found to be contaminated with mycobacterium chimaera, as confirmed by the attached lab report; no patient and user impact was reported.Based on the information provided by service technician during follow-up communication, the device tanks were left full of water until about mid-april, then drained and left empty for the next two months until the date of event.Furthermore, according to what reported to livanova technician by customer, the hydrogen peroxide concentration has not been tested daily, as per heater-cooler 3t system instruction for use cp_ifu_16-xx-xx_eng_017, in the last weeks before the tanks were emptied.Based on the above information, it cannot be ruled out that the most likely root cause of the reported event may be traced back an intermittent water quality monitoring by the user while the unit tanks were full of water, in disagree with heater-cooler 3t system operating instructions.(b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.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: 10274695
• MDR Text Key: 198954545
• Report Number: 9611109-2020-00413
• 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: Recall
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• 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: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1