MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16-02-85

Device Problem Leak/Splash (1354)

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

Event Date 04/21/2023

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in hudson, florida.A livanova field service representative was dispatched to the facility to investigate the device and could not confirm the reported issue, since the device was emptied by the customer.Level sensor shafts were cleaned by livanova technician in case these were sticking preventing the customer from knowing when the patient tank was full.Missing bracket for the vacuum canister was installed.Unit was filled with water and tested: all tests passed showing no signs of leaks.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.

Event Description

Livanova deutschland received a report that a heater-cooler system 3t device was leaking water from front and back, during cleaning operations.There was no patient involvement.

Manufacturer Narrative

H10: based on available information, it cannot be ruled out that leak was caused by the user who inadvertently overfilled the unit during cleaning operation.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; 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: 16959835
• MDR Text Key: 315570687
• Report Number: 9611109-2023-00226
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2010
• 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