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

Model Number 16-02-80

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2019

Event Type  malfunction  

Manufacturer Narrative

There was no 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: k052601).Livanova (b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova initiated an 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 heater-cooler system 3t displayed two error codes associated to the patient side during service.There was no report of patient injury.

Manufacturer Narrative

H.10: a livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported error codes.He traced the fault back to both patient pumps.He replaced the pumps and the issue was solved.Functional verification testing was completed without further issues and the unit was returned to service.The replaced parts were investigated and rust and oxidation on the motor bearing as well as visible residue on impellers and on internal components could be identified.The root cause of the reported event has been traced back to rust and oxidation on the bearing mechanisms as well as residue on impellers and on internal components, due to environmental condition, not allowing the pump motors to rotate freely.Through a device service history analysis under another event involving the same device and reporting the same failure, livanova found out that a duplicate was submitted.The case received and already reported under medwatch # mw-007857 has been voided and this has been taken to capture all the above mentioned information.

Event Description

See initial report.

• 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: 9646528
• MDR Text Key: 196432130
• Report Number: 9611109-2020-00038
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

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: Health Professional
• Device Model Number: 16-02-80
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/30/2020
• Supplement Dates Manufacturer Received: 02/26/2020
• Supplement Dates FDA Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1