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

Model Number 16-02-80

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem No Patient Involvement (2645)

Event Date 06/27/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601).Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).During the repair of the heater cooler 3t device, the technician noted that both patient pumps and the stirrer motor did not work.The functionality of these components was compromised by the defective distribution board.It was confirmed in a separate test that all motors were working perfectly.Probably some water ingress has damaged the board, whereas the reason for the water ingress is unknown.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report that on a heater-cooler system 3t the cold plegia, both patient circuits and stirrer motors do not function.This was detected during maintenance.There was no patient involvement.

Manufacturer Narrative

In the previous report it was stated that: "during the repair of the heater cooler 3t device, the technician noted that both patient pumps and the stirrer motor did not work.The functionality of these components was compromised by the defective distribution board.It was confirmed in a separate test that all motors were working perfectly." probably some water ingress has damaged the board, whereas the reason for the water ingress is unknown." the correct information is the following: "during the repair of the heater cooler 3t device, the technician noted that both patient pumps and the stirrer motor did not work.The functionality of these components was compromised by the defective distribution board.The technician order the new part and during his second visit to complete the repair he found out that also the motor of one patient pump and of the stirrer motor were defective.Thus, he replaced the distribution board, a patient pump and the stirrer motor.Some water was found on the cardioplegia bridge, it is likely that water ingress had damaged the board and the pumps circuit, whereas the reason for the water ingress remains unknown.".

Event Description

See initial report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 8829706
• MDR Text Key: 159518511
• Report Number: 9611109-2019-00572
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 04033817901099
• UDI-Public: 010403381790109911170530
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

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: 16-02-80
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/26/2019
• Supplement Dates Manufacturer Received: 07/18/2019
• Supplement Dates FDA Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1