MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH HEATER-COOLER 3T 200V 50/60HZ; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16-02-95

Device Problems Insufficient Cooling (1130); Noise, Audible (3273)

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

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.Patient information was not provided.G.5.The heater-cooler 16-02-80 is not distributed in the usa, and it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in japan.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, during a procedure, the temperature of the oxygenator connected to the heater-cooler system 3t could not be adjusted lower the one of circulation circuit 1.Medical teal elected to connected the myocardial protection circuit of the hc3t to an artificial lung.Procedure was completed with no issue.There is no report of any patient injury.

Event Description

See intial report.

Manufacturer Narrative

A service technician was dispatched to the facility to investigate the device and could not confirm the reported issue.During extensive testing the device was found working within specifications and no deviations with the cooling system could be identified.During service activity a noisy stirrer motor was detected and consequently the patient bridge was replaced.This issue is not related to the cooling malfunction.Mechanical/electrical checks and subsequent functional verification testing were carried out and completed without further issues.The unit was put back into service.According to the complaints database review no further similar issues have been submitted for this unit since its installation in 2019.Hardware malfunction of device could be excluded and no further complaints have been received for this specific issue on this unit, confirming that the reported event was not device related.The issue is more likely associated to procedure/circuit related factors such as tubing length or due to the simultaneous activation of cardioplegia and patient circuit cooling.As per device instruction for use, the length of the tubing between the heater-cooler and the heat exchanger and the single-use heating/cooling blanket must not exceed 5m.As per the above, the event has been reassessed as not reportable.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: HEATER-COOLER 3T 200V 50/60HZ
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 18939177
• MDR Text Key: 338073147
• Report Number: 9611109-2024-00140
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 04033817901136
• UDI-Public: (01)04033817901136(11)191024
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/22/2024

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: 16-02-95
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/20/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2019
• 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