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

Model Number 16-02-85

Device Problems Electrical Shorting (2926); Power Problem (3010)

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

Event Date 01/15/2024

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.There was no known patient involvement.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in usa.The complained heater cooler was visually inspected and everything looked good.Several conditions were tested to replicate the issue and no tripping could be reproduced.The power switch/circuit breaker was replaced as per recommended troubleshooting.Machine extenisevely tested and returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland has received a report that, durins set up, the power switch of a 3t heater cooler keeps tripping.There was no patient involvement.

Manufacturer Narrative

It has been agreed to replace this machine and to no perform any further testing on this machine.The events mfr report number 9611109-2024-00074 (livanova ref (b)(4), on event date (b)(6) 2024, present report) and mfr report number 9611109-2024-00130 (livanova ref (b)(4), on event date (b)(6) 2024) are the same problem recurred on the same device.The initial service was done on 26 january 2024 (and reported in the intial of 9611109-2024-00074) was then found to not have solved the issue.The issue occurred again and second complaint was logged for which a second service was done on 27 february 2024.A follow up triggered by the second service is being submtted for both 9611109-2024-00074 (present report) and 9611109-2024-00130.Customer complained that the power switch is still intermittently tripping during cases.The following tests have been completed: ran temps all the way down and verified the temps were correct with temperature probe set.Ran temps all the way up, made sure it warmed within the 20 minute period, and verified the temps were correct with temperature probe set.Ran temps all the way back down, made sure it cooled within the 20 minute period, and verified the temps were correct with temperature probe set.This validated that the temps were calibrated properly and that the refrigeration system and heating systems were functioning correctly.Replaced the mains a/c board and associated parts in the ul507 service kit as the next troubleshooting step.Ran the machine for a while to see if it would trip again: ran temps all the way down with all pumps running.Ran temps all the way up with all pumps running.Set all temps to 25c and ran cp cold all the way down and the other circuits all the way up with all the pumps running.Finally the machine was tested for 9 hours with all pumps working, cp cold tank set to 2 degrees and warming all other to 41 degrees.The tripping was not duplicated.Unit has been returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Event Description

See intial report.

Manufacturer Narrative

The device will be not further invesitgated and it will be replaced.If any additional information pertinent to the reported event is received, it will be provided in a supplemental 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 GMBH; 14401 w 65th way; arvada 80004 ; GM 80004
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 18685072
• MDR Text Key: 336210372
• Report Number: 9611109-2024-00074
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 04033817900528
• UDI-Public: (01)04033817900528(11)211021
• 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,Followup
• Report Date: 05/07/2024

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: 01/15/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 02/26/2024; 04/11/2024
• Supplement Dates FDA Received: 03/27/2024; 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2021
• 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