3T Heater Cooler System, REF: 16-02-85

FDA device recall Z-0073-2024 · posted 2023-10-06 · Open, Classified

Recall details

Recalling firm

LivaNova Deutschland GmbH

Reason for recall

The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.

Action taken

On August 3, 2023 and August 28, 2023, LivaNova issued a "Urgent Medical Device Correction" notification to affected consignees via E-Mail. LivaNova asked consignees to take the following actions: With the help of Attachment 1 of this letter, identify the location of the 3T Heater- Cooler device(s) where there may be an incorrect QRG. 2. Dispose of only the Quick Reference Guide rev 22 (bound of laminated pages). A new copy of the quick reference guide will be delivered to your facility as soon as possible. 3. Check whether the maintenance schedule reported in OI section 6.2.1 was followed. A. In case YES: You do not need to take any further action and you can continue to use the 3T device according to the OI. B. In case NO, B.1. Replace the aerosol collection if needed (ref. OI section 5.7.2) B.2. Disinfect the water circuit (ref. OI section 6.4) B.3. Monitor the water quality (ref. OI section 6.5.2) B.4. Remove the system from service until you receive the results of the water quality monitoring. B.5. In the case of Acceptable bacteria and NTM count (ref OI section 6.5.2 paragraph 4) you can continue to use the 3T device according to the OI. B.6. In case of Unacceptable bacteria and NTM count (ref OI section 6.5.2 paragraph 4), keep the system out of service, and contact your hygiene officer and your authorized service technician. LivaNova can provide an optional Deep Cleaning service for the system free of charge. Please contact your service technician or sales representative to request this service. 4. Fill in and sign the Customer Response Form (Attachment 1), and return it by email to LivaNova.FSCA@livanova.com or by hand to your LivaNova contact person, to confirm that you have received this letter, you have read and understood its content, you have disposed the incorrect copy and you have received the corrected QRG laminated cards. 6. Please ensure that this Medical Device Correction is communicated to all personnel within your organization who need to be

Root cause

Labeling Change Control

Status

Open, Classified

Product code

DWC

Quantity affected

37 systems

Distribution

US Nationwide distribution in the states of CA, IN, GA, NC, TX, AZ, FL, MN, NJ, CO, SC.

Date initiated

2023-08-03

Date posted

2023-10-06

Location

Munich, Germany

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