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

Model Number 16-02-80

Device Problem Electrical Shorting (2926)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/18/2022

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: k191402).Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in murdock, australia.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.Unit was found to have a hole in cooling coil, causing water to leak into cooling compressor unit and then tripping the rcd.The device will not be repaired and a loaner will be provided to the customer.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that a heater-cooler system 3t tripped the rcd (residual current device) when compressor switched on during cooling.There was no patient injury.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15208047
• MDR Text Key: 298491056
• Report Number: 9611109-2022-00412
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 04033817901099
• UDI-Public: 010403381790109911170816
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2017
• 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