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

Model Number 16-02-80

Device Problems No Display/Image (1183); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2017

Event Type  malfunction  

Manufacturer Narrative

Pma 510(k): the heater-cooler device 16-02-80 is not distributed in the usa.However, it is similar to the heater-cooler device 16-02-85, which is distributed in the usa (510(k) number: k052601.Livanova (b)(4) manufactures the heater-cooler system 3t.The event occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).A livanova field service representative was dispatched to the facility to investigate.The service representative was not able to confirm the reported issue.The device was run for 2.5 hours without issue.A thorough internal inspection was unable to identify any abnormalities or defects.The device was turned on and was run in various modes (cooling, warming, circulating, etc.) and no errors occurred.An electrical safety check was successfully completed.During follow-up communication with the customer, the service representative learned that an extension cable was in use at the time of the event.The customer identified that one of the sockets on the extension lead was faulty.It could not be confirmed if this was the cause of the reported issue.However, no device malfunction was identified during testing.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Evaluated on site by livanova rep.

Event Description

Livanova (b)(4) received a report that the display of the heater-cooler system 3t went blank and the device stopped working during a procedure.There was no report of patient injury.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; munich, CO 80004 ; 2812287260
• MDR Report Key: 6723037
• MDR Text Key: 80428873
• Report Number: 9611109-2017-00543
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1