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

Model Number 16-02-80

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/23/2020

Event Type  malfunction  

Manufacturer Narrative

There was no known patient involvement.The heater-cooler 16-02-80 is not distributed in the usa and it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402.Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova initiated an investigation.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.Device has been replaced at customer site.Device will return to manufacturing site.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received a report about error message on heater cooler device.Operation of the patient pumps not possible.No evidence of any patient involvement.

Event Description

See initial report.

Manufacturer Narrative

H.10: a review of the dhr could not identify any deviations or nonconformities relevant to the issue.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.Despite replacements of processor and distributor board, the issue persisted.The unit will be repaired at the manufacturer site.The most likely root cause of the reported event is a defective stirrer motor.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 10435685
• MDR Text Key: 204583933
• Report Number: 9611109-2020-00473
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

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: No Information
• Device Model Number: 16-02-80
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 09/15/2020
• Supplement Dates FDA Received: 10/15/2020
• Patient Sequence Number: 1