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

Model Number 16-02-85

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.This event was initially considered to be non-reportable.However, after additional evaluation, livanova (b)(4) has decided to reclassify this event as reportable.This report is being filed as part of a retrospective review conducted in response to this new decision.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.He rolled the device into the or and shortly after he turned on the unit the line isolation monitor (lim) alarmed.The service representative disconnected the connector for the cardioplegia heater and the unit did not trigger the lim.It was concluded then that the cardioplegia heating element is the cause of the reported issue.The cardioplegia heating element was replaced and an overall function test was performed and passed with no further issue identified.The device was returned to service.If additional information will be received for this case, they will be provided in a supplemental report.Evaluated on site by livanova technician.

Event Description

Livanova (b)(4) received a report that the heater-cooler system 3t tripped the line isolation monitor (lim) alarm in the or room during a procedure.There was no report of patient injury.

Manufacturer Narrative

The replaced heating element was returned to livanova (b)(4) for further investigation.During evaluation of the returned device, the reported failure could not be confirmed.The device worked according the specification.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.As the issue could not be reproduced, a root cause was not identified.

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 80939 ; GM 80939
• MDR Report Key: 7206989
• MDR Text Key: 97969532
• Report Number: 9611109-2018-00066
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K052601
• 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: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1