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

Model Number 16-02-95

Device Problem Electrical Shorting (2926)

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

Event Date 03/18/2024

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.Patient information was not provided.G.5.The heater-cooler 16-02-95 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 the early stages of the operation, the power of a heater-cooler system 3t that went out about 4 times.After that, the issue did not reoccur and procedure was completed with no issue.There is no report of any patient injury.

• Brand Name: HEATER-COOLER 3T 200V 50/60HZ
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• 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: 19103778
• MDR Text Key: 340461979
• Report Number: 9611109-2024-00178
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 04033817901136
• UDI-Public: (01)04033817901136(11)191017
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/15/2024

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/17/2019
• 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