MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM; Controller, temperature, cardiopulmonary bypass

Model Number 400CE

Device Problem Insufficient Heating (1287)

Patient Problem Unspecified Heart Problem (4454)

Event Date 12/05/2022

Event Type  malfunction  

Manufacturer Narrative

Complaint #(b)(4) received.There were no allegations of patient harm.The device was not returned to the manufacturer.The device was evaluated at the facility and determined to have a faulty heater assembly.

Event Description

During surgery in cvts ot, user try to reach their target temperature but its very much slowly heating.

• Brand Name: HEMOTHERM
• Type of Device: Controller, temperature, cardiopulmonary bypass
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller rd; cincinnati OH 45241
• Manufacturer (Section G): GENTHERM MEDICAL, LLC; 12011 mosteller rd; cincinnati OH 45241
• Manufacturer Contact: angie gegner ; 12011 mosteller rd; cincinnati, OH 45241 ; 5133265228
• MDR Report Key: 16086284
• MDR Text Key: 308349454
• Report Number: 1516825-2022-00009
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 10613031860238
• UDI-Public: (01)10613031860238
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K122813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 400CE
• Device Catalogue Number: 86023
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1