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 02/06/2024

Event Type  malfunction  

Event Description

Livanova deutschland received a report that a heater-cooler system 3t displayed alarm on patient side during a procedure.The alarm was silenced and procedure completed.There is no report of any patient injury.

Manufacturer Narrative

A.1.-a.5.Patient information was not provided.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in usa.There is no ¿error code¿ for this issue and is a light that looks like the outline of a person that illuminates when the patient side temperature is outside of the limit.The livanova field service representative in charge calibrated the patient safety limit and upper and lower temperature limits.Let run at the upper temperature for an hour to test - no failures.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H10: complaints database analysis revealed no similar event since unit installation in 2015.As per what reported in the device instructions for use the symbol light up when the maximum deviations between the patient¿s temperature and the water temperature during heating/cooling have been exceeded.In these cases the customer have to follow the following steps in case of pumps stop: adjust the values for the maximum deviation (¿delta¿) on the menu (performed by the field service technician during the on-site visit); wait until the deviation drops within the normal tolerance range again.Then, start the pumps again; keep the water circuit running (if necessary) by continuously pressing the corresponding circuit start/stop key.Based on the above and considering that no hardware failure has been found by the field service technician, the most likely root cause of the alarm was the exceeding patient temperature limits due to specific circuit setup and heater cooler settings.

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 CO 80939
• 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: 18854437
• MDR Text Key: 337688780
• Report Number: 9611109-2024-00121
• 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: 05/20/2024

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: 16-02-85
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 05/20/2024
• Date Device Manufactured: 09/09/2015
• 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