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

Model Number 16-02-80

Device Problems Mechanical Jam (2983); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 05/10/2019

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).A livanova field service representative identified the issue during the maintenance of the device.The service representative was able to confirm the reported issue.The technician replaced the whole patient bridge to resolve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The patient bridge was requested back to livanova (b)(4) for further investigation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported 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 a stirrer motor of a heater-cooler system 3t failed to turn and was found to be noise when turned by hand.This issue was identified by a livanova field service representative during maintenance.There was no patient involvement.

Manufacturer Narrative

H.10: the affected part was requested back for further investigation.The complete patient bridge was received and investigated.Results revealed that the weld of the pump connection was broken and the stirrer motor electronics were found to be defective.Moreover, all pumps bearings were found to be rusted and one of those also had a defective electronics.A combination of both mechanical issues and electronic defects may have led to the reported issues.However, since all failures popped up after the overfilling of the device during routine cleaning, the most likely root cause is traceable to electronics damages caused by water ingress.

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: 8690137
• MDR Text Key: 147778304
• Report Number: 9611109-2019-00449
• 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: company representative
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• 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 Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1