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

Model Number	16-02-82
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova (b)(4) received a report that a heater-cooler system 3t had a defective cooling compressor.There was no report of patient injury.
Additional Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).The customer reported that hole on the cooling coil was found.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Hospital has biomedical engineers.
Additional Manufacturer Narrative
H.10: through follow up communication livanova received confirmation that no patient was affected and it was learned that for this device regular maintenance was done according to the manufacturer ifu.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
H.10: the unit was returned to munich for repair activity.The issue was confirmed.The evaporator was found to be leaking thus water entered the cooling circuit leading to the fuse trip.Complaints database review was performed and revealed that a complaint regarding nickel plating detachment from the evaporator coil was submitted in 2019.However, at the time, the functionality of the unit was not compromized.The reported event is a known issue.Livanova put in place corrective action to reduce this type of events in case of breach of the cooling coil being generated due to stirrer flow in the tank leading to hole formation in a narrow area of the coil.However, in this specific case, the exact location of the hole on the cooling coil could not be determined.In (b)(6) 2019 it was performed the erosion kit upgrade of the device that includes the new design of the pump head of the stirrer motor to prevent the water flow directed to the narrow area of the cooling coil.The reported event was claimed after the upgrade but considering the previous complaint of detachment of nickel plating, it cannot be ruled out that the condition of the evaporator was already compromised before the upgrade to such an extent that the copper was rather degraded.
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: 14155364
• Report Number: 9611109-2022-00174
• Device Sequence Number: 20236274
• Product Code: DWC
• UDI-Device Identifier: 04033817900511
• UDI-Public: (01)04033817900511(11)170629
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2022

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: 16-02-82
• 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: 03/21/2022
• Supplement Date Received by Manufacturer: 05/19/2022; 07/19/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 06/16/2022; 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2017
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown