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

Model Number 16-02-95

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Ventricular Fibrillation (2130)

Event Date 02/13/2017

Event Type  malfunction  

Manufacturer Narrative

The heater-cooler 16-02-95 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).(b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is being filed on behalf of (b)(4).It is not clear from the reported incident if the patient has been affected by ventricular fibrillation or not.(b)(4) has inquired for additional information regarding the patient status.However, the customer responded asking if ventricular fibrillation could be caused by the described event.The customer stated that they did not know if the customer would recover.Additional attempts have been made to gather more information about the patient status.No further information has been received.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The investigation is on-going.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.

Event Description

(b)(4) received a report that the heater-cooler system 3t displayed a numeric error code once during priming and again approximately 7 hours later when the circulation button was pressed during the procedure.The first time, the user restarted the device and continued use of the unit.It reportedly took 10 minutes to resolve the issue and during this time, it was not possible to give warm blood back to the patient.The customer reported that the issue may have caused ventricular fibrillation.

Manufacturer Narrative

A livanova field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported issue and traced the failure to defective sensors.The technician replaced all temperature sensors to resolve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.No further investigation on the parts could be performed as the sensors were scrapped.

• 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; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6404818
• MDR Text Key: 69945449
• Report Number: 9611109-2017-00174
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-95
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2015
• 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
• Patient Outcome(s): Other