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

Model Number 16-02-80

Device Problems Thermal Decomposition of Device (1071); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 05/24/2017

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).(b)(4).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 fault to a blown warm cardioplegia heating element.Black scorch marks were identified at the entry point of the element into the tank and at and around the heating element connection to the ac mains board.The connector could be removed from the board due to the welding inside of the connector.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.At this time, the customer has not decided if they would like a repair to be carried out or if the device will be scrapped due to age.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device availability unknown.

Event Description

Livanova (b)(4) received a report that the heater-cooler system 3t made a noise and the user noted a burning smell coming from the device during a disinfection procedure.The device was removed from service.There was no patient involvement.

Manufacturer Narrative

The heating element and the corresponding connection were sent for investigation.Visual inspection of the returned components confirmed the reported issue.The heater elements have been found fully functional.A specific root cause of the reported issue could not be identified.It is most likely that the reported event is related to the observed corrosion, caused by condensation between the stainless steel heater and the mounting plate of the impacted heating element.

• 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: 6663878
• MDR Text Key: 78297076
• Report Number: 9611109-2017-00478
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2004
• 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