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Heater-Cooler System recallZ-0073-2024 · LivaNova Deutschland GmbH · initiated Aug 3, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from LivaNova Deutschland GmbH or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Labeling Change Control

What the company is doing

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 [email protected] 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

Recall details

Recall number
Z-0073-2024
Status
Open, Classified
Initiated by the company
Aug 3, 2023
Posted by the FDA
Oct 6, 2023
Recalling firm
LivaNova Deutschland GmbH
Quantity
37 systems
Product code
DWC
FDA submissions
K191402
Distribution
US Nationwide distribution in the states of CA, IN, GA, NC, TX, AZ, FL, MN, NJ, CO, SC.

Product description

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

Code information (models, lots, serial numbers)

UDI: (01)04033817900528/ Serial Numbers: 20T31334, 20T31336, 20T31366, 20T31391, 20T31375, 20T31322, 20T31348, 20T31345, 20T31362, 20T31363, 20T31364, 20T31407, 20T31531, 20T31532, 20T31534, 20T31367, 20T31368, 20T31369, 20T31370, 20T31371, 20T31372, 20T31373, 20T31386, 20T31387, 20T31388, 20T31389, 20T31390, 20T31550, 20T31551, 20T31552, 20T31553, 20T31543, 20T31544, 20T31536, 20T31346, 20T31347, 20T31361, 20T31365

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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