MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16-02-81

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 03/24/2015

Event Type  Death  

Manufacturer Narrative

Patient information was not provided.Serial number is unknown.This information will be provided in a supplemental report if made available.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.Livanova (b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Through media monitoring process livanova became aware of a patient death due to bacterial infection allegedly associated with the use of a heater cooler device during the surgery.Within the newspaper article there is no additional information regarding surgery date, date of patient death, device used and patient details.

Manufacturer Narrative

H.10: through follow-up communication with the customer livanova learned that: the model number provided by the customer is 16-02-81.The exact device used cannot be determined since the serial number was not tracked at the time of the surgical date.The device was not retained.Reportedly, all heater cooler 3t devices at the site were decommissioned in 2018 and replaced with new devices.The patient underwent an aortic valve replacement, excision left atrial appendage and repair of ascending aorta.The surgery date was (b)(6), 2015.Thus, no heater cooler was upgraded with vacuum and sealing kit at the time of 2015 surgery.The patient was diagnosed as positive to mycobaterium chimera infection on (b)(6), 2020.No further information about the patient can be provided due to alberta privacy laws.Livanova contacted the customer to collect additional information regarding device cleaning and maintenance practice.The customer replied that the response may be delayed by a few weeks due to summer vacations.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

H.10: through follow-up communication with the customer livanova learned that: customer did not perform microbial test before 2015 and that tests were performed after (b)(6) 2015 and found devices to be contaminated samples from devices were taken after (b)(6) 2015 procedures and found to be positive to m.Chimaera if the device was cleaned in accordance with the instructions for use valid at the time of the intervention the devices were cleaned according to device instruction for use valid at the time of the intervention.Reportedly, any update regarding cleaning protocol that was received from livanova were implemented immediately upon receipt.The fan of device was oriented away from the surgical field filtered water was used single use patient blankets were used the water sources were not routinely sampled prior to the outbreak of m.Chimaera but the customer sampled after awareness of the outbreak if any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Event Description

See initial report.

Manufacturer Narrative

A typing error was done in the previous supplemental report.It was reported that: "- customer did not perform microbial test before 2015 and that tests were performed after (b)(6) 2015 and found devices to be contaminated - samples from devices were taken after (b)(6) 2015 procedures and found to be positive to m.Chimaera - if the device was cleaned in accordance with the instructions for use valid at the time of the intervention - the devices were cleaned according to device instruction for use valid at the time of the intervention.Reportedly, any update regarding cleaning protocol that was received from livanova were implemented immediately upon receipt.- the fan of device was oriented away from the surgical field - filtered water was used - single use patient blankets were used - the water sources were not routinely sampled prior to the outbreak of m.Chimaera but the customer sampled after awareness of the outbreak." please consider valid the text below: "- customer did not perform microbial test before 2015 and that tests were performed after (b)(6) 2015 and found devices to be contaminated - samples from devices were taken after (b)(6) 2015 procedures and found to be positive to m.Chimaera - the devices were cleaned according to device instruction for use valid at the time of the intervention.Reportedly, any update regarding cleaning protocol that was received from livanova were implemented immediately upon receipt.- the fan of device was oriented away from the surgical field - filtered water was used - single use patient blankets were used - the water sources were not routinely sampled prior to the outbreak of m.Chimaera but the customer sampled after awareness of the outbreak." h.10: the serial number was not provided.However, analysis of current installed base of the customer reveals that the devices potentially used during the surgery could be the following (all manufactured in 2007) : (b)(6).Through further follow-up communication livanova retrieved laboratory test results on machine in use at the hospital.As reported by the customer, the hospital did not perform microbial test before 2015 and that tests were performed after (b)(6) 2015 and found devices to be contaminated.However, provided results on the machine were related to tests conducted in the summer of 2016 (more than 1 year after the surgery date) and provided information are not sufficient to determine if the device used during surgery was contaminated or not and if it was contaminated at the time of surgery in (b)(6) 2015.In addition, as reported in the previous report, the water sources were not routinely sampled prior to the outbreak of m.Chimaera but the customer sampled after awareness of the outbreak.However, through additional follow up communication with the customer to obtain the water sources test results , it was learned that this type of test was not completed at the time.Based on collected information, a direct relationship between the reported adverse event and the device could not be determined.

• 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 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 13541352
• MDR Text Key: 285683091
• Report Number: 9611109-2022-00070
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-81
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2022
• 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