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

Model Number 16-02-80

Device Problems Fluid/Blood Leak (1250); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 09/19/2017

Event Type  malfunction  

Manufacturer Narrative

The heater-cooler device 16-02-80 is not distributed in the usa.However, it is similar to the heater-cooler system 3t device 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).A livanova field service representative was informed by the customer that a third party service provider identified a faulty compressor to be the root cause of the reported event.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 failed during priming due to earth leakage of the compressor caused as a result of a leak in the device water tanks.There was no patient involvement.

Manufacturer Narrative

Through further follow-up communication with the customer, livanova learned that the hospital performed the investigation and determined that the fault was caused by a leakage in one of the watertanks.Based on internal livanova investigation, it was determined that in specific conditions a hole can be generated in a defined area of the evaporator located in the patient tank.Such hole might create a leak of refrigerant in the tank and consequent water ingress in the cooling circuit.Such situation would then damage the compressor.The hospital declined to send the device back for further investigation.Therefore, no further investigation is possible.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: 6942875
• MDR Text Key: 90312316
• Report Number: 9611109-2017-00805
• 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: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-80
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2009
• 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