MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH HEATER/COOLER 3T 110V/60 HZ; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16-02-85

Device Problem Temperature Problem (3022)

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

Event Date 12/28/2023

Event Type  malfunction  

Event Description

Livanova deutschland has received a report that, during the weekly disinfection, the 3t hater cooler displayed pump 3 uses too much power errror (patient circuit: e21).There was no patient involvement.

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in united states.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H10: in the previous submitted report (mfr# 9611109-2024-00040), it was incorrectly reported that error code e21 is associated to pump 3.The correct pump is patient circuit 2.A livanova field service technician was dispatched to the facility to investigate the device and could reproduce the reported issue.When opening the unit, it was found that the stirrer motor and the patient 2 pump were locked up.In order to fix the issue, patient circuit bridge, that includes the stirrer motor and patient pump 2, and the distribution board were replaced.Subsequent functional verification testing was completed without further issues and unit was returned to service.No other event of this error code (e21) has been recorded on the device since its installation in 2011 by reviewing the complaints database.Based on the collected information, it is reasonable to trace the root cause of the reported error code back to patient pump 2 and stirrer motor stuck or no longer moving freely and to a faulty distribution board.Indeed, it cannot be excluded that because of rusted/corroded/damaged motor bearings, likely due to environmental conditions, such as water infiltration, humidity, condensation, high temperatures in the stationary phase, the pumps were no longer rotating freely and required a power overload to work, which could have led to an over-current that ultimately caused damage to the distribution board.

Event Description

See initial report.

• Brand Name: HEATER/COOLER 3T 110V/60 HZ
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18518266
• MDR Text Key: 333488859
• Report Number: 9611109-2024-00040
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2011
• 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