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

Model Number 16-02-80

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 10/16/2017

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).This medwatch report is being filed on behalf of livanova (b)(4).The device has been returned to livanova (b)(4) for investigation and repair.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.

Event Description

Livanova (b)(4) received a report that the compressor of a heater-cooler system 3t did not work during priming.There was no patient involvement.

Manufacturer Narrative

The unit was returned to livanova (b)(4) for further investigation.During the investigation the reported issue could be confirmed and a hole inside the evaporator was identified as root cause of the reported failure.Corrective actions are in progress for this 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
• 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: 7011016
• MDR Text Key: 92496525
• Report Number: 9611109-2017-00905
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2015
• 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