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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2023

Event Type  malfunction  

Event Description

Livanova deutschland received a report that a heater-cooler system 3t device was found to be microbiologically contaminated during weekly test of the water.There is no report of patient injury.

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.G.5.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).H.9.Livanova deutschland implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in (b)(6) belgium.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

Throught follow up livanova learned the device is cleaned regularly.The hospital does not use reusable blankets, the water quality monitoring is applied and the h2o2 checked every day as prescribed by the ifu, the device is in use every day, the h2o2 is checked daily but not in the weekend, h2o2 is added when the water in the tanks is changed (each 7 days), a disposable pall-aquasafe water filter with an 0.2 m membrane (or equivalent performance filter) is used for tap water, prior to initial operation and prior to storing the heater-cooler the surfaces and water circuits are disinfected and device surfaces are disinfected once a week, the 3t aerosol collection set is replaced after the allowed use period.The device is placed outside the operation theatre during use.As per the above, the device is not cleaned after every operations and h2o2 is checked every day but not in the weekend.This is not in accordance with ifu.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

It cannot be excluded that highlighted deviation from ifu's may have contributed to reported contamination.Livanova has implemented a strategy to progressively decrease the probability of bacteria growth in the hc device by applying multiple measures implemented over the past few years through dedicated capa and field action.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See initial report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 18417462
• MDR Text Key: 331595779
• Report Number: 9611109-2023-00663
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 04033817901099
• UDI-Public: (01)04033817901099(11)170529
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-80
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/29/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1