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

Model Number 16-02-82

Device Problem Degraded (1153)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2022

Event Type  malfunction  

Event 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.

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.

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 Description

See initial report.

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 Description

See initial report.

• 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: 14155364
• MDR Text Key: 289689215
• Report Number: 9611109-2022-00174
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 04033817900511
• UDI-Public: (01)04033817900511(11)170629
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K191402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 16-02-82
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 04/20/2022
• Supplement Dates Manufacturer Received: 05/19/2022; 07/19/2022
• Supplement Dates FDA Received: 06/16/2022; 08/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/29/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1