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 Bacterial Infection (1735)

Event Date 08/03/2012

Event Type  Injury  

Manufacturer Narrative

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).Livanova initiated an investigation.This report was due on december 02, 2023; however, due to a network disruption at livanova, the ability to submit mdrs was lost on november 19, 2023, before this report was ready to submit.The report was prepared and submitted immediately following restoration of the livanova systems.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Complainant alleges through their counsel infection with mycobacterium chimaera following a surgery carried out on (b)(6) 2012, in which a heater-cooler system 3t was used.No additional information was provided.Based on current status of the investigation the alleged device issue was yet not confirmed.

Event Description

See intial report.

Manufacturer Narrative

Legal lawsuit has been issued and no other information has been made available.Due to on-going litigation, it is very likely that the customer will not release further information related to the status of the devices or patients.It is unknown if the reported infection is related to the use of the heater-cooler device.A dhr review could not be performed since possible serial numbers involved were not provided.Source of patient contamination remains unknown and the livanova device involvement as well.Livanova already implemented a strategy to decrease the probability of bacteria grow in the hc device by applying multiple measures implemented over the past few years through dedicated capa and field action.Involved device serial number remained unknown and was not equipped with vacuum and sealing kit since upgrade activity started in 2017 (surgery of the patient was carried out on (b)(6) 2012).

Event Description

See initial report.

Manufacturer Narrative

D4.The event is related to a legal case and in order to collect additional information from customer is requiring the involvement of legal department.For this case different attempts were made and no additional information can be collected, neither the serial number of the device.

• 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; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18417673
• MDR Text Key: 331582524
• Report Number: 9611109-2023-00668
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-80
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 05/31/2024; 08/02/2024
• Supplement Dates FDA Received: 06/25/2024; 08/02/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other
• Patient Sex: Male