MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH HEATER COOLER 3T (208 VOLT)(FOR USA AND; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16-02-82

Device Problem Temperature Problem (3022)

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

Event Date 01/24/2024

Event Type  malfunction  

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.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 displayed on patient side an error indicating pump 1 uses too much power (ee6), during set up before procedure.There was no patient involvement.

Event Description

See initial report.

Manufacturer Narrative

A livanova service technician was dispatched to the customer's facility, inspected the unit and found the issue was related to cardioplegia side (patient side not affected).The problem was solved by replacing the the cardioplegia pump.Functional verification checks were performed and passed positively.The unit was put back in service.A device service history review has been performed and identified that the unit was manufactured in 2016 and no other similar events have been reported.Based on all above facts, considering the results of a similar complaints database analysis and the manufacturing date of the device, it cannot be ruled out that the most likely root causes of the reported event are a corroded/damaged motor bearings, probably due to environmental conditions and disinfection procedures or wear of the bushings, due to a misalignment of the motor shaft.No specific action was currently deemed necessary, livanova maintains and document periodic customer events monitoring process in order to evaluate actions for products improvement.From field service technician: based on the information received, the event has been reassessed as not reportable.Cardioplegia pump malfunction is not likely to result is death or serious injury since cardioplegia solution is delivered in small volumes and at regular intervals allowing the user to perform cooling/heating through alternative methods (i.E.Ice for cooling) or to use another circuit of the device.Thus, temperature management on cardioplegia side is not critical.

• Brand Name: HEATER COOLER 3T (208 VOLT)(FOR USA AND
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939
• 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: 18747443
• MDR Text Key: 336969458
• Report Number: 9611109-2024-00091
• 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: 04/02/2024

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: 16-02-82
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 01/26/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2018
• 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