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

Model Number	16-02-85
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Based on information provided the customer may have deviated from device instruction for use regarding cleaning and maintenance of device and regarding the sampling as well.In detail, the following was mentioned: - use of wipes different from the one stated in the instruction for use.- hydrogen peroxide check not conducted daily even if the device was stored full of water.- customer not using sterile containers and sealed lids for water samples.- sampling technique: drain ports not being spayed/wiped.In addition, the customer is questioning the accuracy of laboratory test results.It is not yet clear if the above mentioned anomalies identified have been corrected by customer or not.Based on the current level of information, a contamination of the samples cannot be excluded.However, any of the above mentioned deviation from device instruction fo ruse may have led/contributed to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova (b)(4) received a report that a heater-cooler system 3t was found to be contaminated with mold like fungus (tmtc).There is no known patient involvement.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H.10: through follow-up communication, the customer reported that the devices are cleaned constantly.However, it is still unclear if deviations from device instruction for use have been resolved.In addition, it was learned that a source of mycobacterium chelonae was identified by the customer.In detail, it was reported that one of the faucets is growing the bacterium and that sink does not have enough chlorine.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H.10: as stated in the initial report, the customer deviated from device instruction for use regarding cleaning and maintenance of device: use of wipes different from the one stated in the instruction for use.Hydrogen peroxide check not conducted daily even if the device was stored full of water.Customer not using sterile containers and sealed lids for water samples.In addition, as reported in the previous supplemental report, a source of mycobacterium chelonae was identified by the customer.In detail, it was reported that one of the faucets was growing the bacterium and that sink did not have enough chlorine.Moreover, customer questioned accuracy of laboratory reports.Based on the collected information, it can be concluded that the most likely root cause of the reported event is related to hospital faucet being contaminated and a contribution of the above mentioned deviations from the instruction for use cannot be excluded.
Event or Problem Description
See initial report.

• 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 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 13974362
• Report Number: 9611109-2022-00150
• Device Sequence Number: 6229221
• Product Code: DWC
• UDI-Device Identifier: 04033817900511
• UDI-Public: 010403381790051111170223
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 03/30/2022

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: 16-02-85
• 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: 03/04/2022
• Supplement Date Received by Manufacturer: 04/04/2022; 05/26/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 05/05/2022; 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2017
• 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