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

Model Number 16-02-85

Device Problems Thermal Decomposition of Device (1071); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.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.The service representative was able to confirm the reported issue.The technician identified that the blocked patient pump led to a burned resistor on the distribution board.The patient pump and distribution board were replaced to resolve the reported malfunction.Subsequent functional verification testing was completed without further issues and the unit was returned to service.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.Device not returned.

Event Description

Livanova (b)(4) received a report that a heater-cooler system 3t displayed an error code and smoke was observed exiting the device during maintenance.There was no patient involvement.

Manufacturer Narrative

The defective pump was returned to livanova (b)(6) for further investigation.The visual inspection revealed that the pump is dirty and the electronics on the pump is defective.

Manufacturer Narrative

In the initial report was reported that: "the technician identified that the blocked patient pump led to a burned resistor on the distribution board.The patient pump and distribution board were replaced to resolve the reported malfunction." the correct narrative is as below: "the technician found out burnt resistor on the distribution board so he replaced it but also the new board burnt out.Thus, he identified that the patient pump was damaging the boards.The patient pump and distribution board were replaced to resolve the reported malfunction." investigation results revealed that both distributor boards had high impedance resistors.The pump motor electronics defects were most likely caused by the overfilling of the machine.Defective pump circuit boards damaged the resistors on the distributor boards causing the reported event.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 89309
• Manufacturer Contact: njemile crawley ; 14401 w. 65th way; arvada, CO 80004 ; 2812287575
• MDR Report Key: 7551423
• MDR Text Key: 109516948
• Report Number: 9611109-2018-00999
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052601
• 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,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• 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 Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2008
• 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