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 05/12/2014

Event Type  Death  

Event Description

Complainant alleges through their counsel a mycobacterium chimaera infection acquired post-operatively following a heart valve surgery (date unknown) in which a heater-cooler system 3t device was used.Patient died.

Manufacturer Narrative

D.4.Serial number is unknown.This information will be provided in a supplemental report if made available.H.4.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.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 coventry, united kingdom.Through follow up communication, livanova learned that possible involved device serial numbers could be the following: (b)(6) (model: 16-02-80).No other information has been made available from the customer.Device history records (dhrs) review of possible involved device serial numbers has been completed and did not identify any deviation or non-conformity relevant to the reported issue.No device between the ones possible involved and in use at the hospital at the time of surgery (2014), was equipped with vacuum and sealing kit since upgrade activity started in 2017.No further investigation is possible.Source of patient contamination remains unknown and a direct relationship between the reported adverse event and the device could not be established.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• 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: 18844763
• MDR Text Key: 336963422
• Report Number: 9611109-2024-00115
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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

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?: 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
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 03/06/2024
• 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): Death
• Patient Sex: Male