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

Model Number	3T 208V ~ / 60HZ
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova (b)(4) received a report that, the laboratory of (b)(6) 2020 show contamination with ntm chimera.There was no patient involvement.
Additional Manufacturer Narrative
There was no known patient involvement.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).Laboratory results provided by the customer showed ntm positive results.However, pcr analysis of the sample did not confirm identify the chimera strain contamination.The complained heater-cooler device (16s17344) is used as loaner.The device was used by iucpq and returned to livanova (b)(4) in (b)(6) 2020.Livanova was informed on the (b)(6) 2020 positive results in (b)(6) 2022.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
Sn (b)(6) of the involved heater cooler 3t system was added to section d.4 (serial number).The serial number of the device was reported only in section h.10 of the initial report due to a copy and paste error.H10: please consider invalid the following sentence reported in the initial report: "pcr analysis of the sample did not confirm identify the chimera strain contamination." and consider valid the following information received through further follow up communication with the customer: "through follow-up communication livanova learned that mycobacterium tuberculosis complex identification analysis is always carried out by the customer on clinical samples first.If the outcome is negative, customer proceeds with the identification of the non-tuberculous mycobacterium.In this specific case, since it was an environmental sample, identification analysis of the mycobacterium tuberculosis complex was not necessary.The identification at sample sequencing was mycobacterium chimaera." moreover, through follow-up communication under previous complaint from the same hospital in 2020, livanova learned that the device was cleaned regularly as per instructions for use and it is placed inside the operation theatre with fan directed away from surgical field at distance of two (2) - four (4) meters.In addition, reusable heating blankets for the patient are not used.No evident or systematic deviation from device instruction for use could be identified in this specific case.However, the source of contamination is most likely related to location where device is used/stored.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Common Device Name: 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: 14237433
• Report Number: 9611109-2022-00197
• Device Sequence Number: 14645988
• Product Code: DWC
• UDI-Device Identifier: 04033817900511
• UDI-Public: (01)04033817900511(11)161215
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K191402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3T 208V ~ / 60HZ
• Device Catalogue Number: 16-02-82
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2076/2081-2015
• Patient Sequence Number: 1
• Patient Sex: Unknown