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

Model Number 16-02-80

Device Problem Insufficient Heating (1287)

Patient Problem No Patient Involvement (2645)

Event Date 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.The heater-cooler 16-02-80 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).Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).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 the temperature of a heater-cooler system 3t is not stable and jumps sporadically by 2 degrees during priming.There was no patient involvement.

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 replaced all possible boards and ribbon cables, as well as the thermometer.However, the issue persisted.The components were installed back into the device and the unit was returned to livanova (b)(4) for investigation.The device was returned to the original equipment manufacturer for evaluation, which revealed that the connecting cable of the stepper motor was rubbing on the pump motor, causing a sporadic short circuit, which disrupted the electronics and caused the temperature display to become erratic.It could not be determined how the cable became loose.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

• 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: 7352400
• MDR Text Key: 103182877
• Report Number: 9611109-2018-00241
• 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: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• 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
• Date Manufacturer Received: 03/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1