MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 400CE

Device Problem Overheating of Device (1437)

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

Event Type  malfunction  

Event Description

The customer claims that this hemotherm ce unit had black smoke coming from the power supply board while in the operating room, the patient was not injured.

Manufacturer Narrative

Complaint #(b)(4) received.There were no allegations of patient harm.Customer has not released the device for evaluation.

Manufacturer Narrative

Device was received on may 11, 2023 and evaluated on june 20, 2023.The evaluation confirmed the issue that the power board experienced overheating.During the evaluation, it was noted that this device was identified to be part of a field action (fda recall z-0825-2019 / recall event id #(b)(4) - recall termination date: 04/24/2020) where the power board was required to be replaced.This device did not have the upgraded power supply board installed per the field action but instead had the original power supply board that was required to be replaced.A medical device correction notification was sent to the customer in december 2018.The customer returned a correction response form in february 2019, acknowledging the notification and its requirment to replace the power supply board.However, the customer did not replaced the original power supply board in this device as required.Additionally, an investigation was conducted and completed december 7, 2023.Gentherm concludes that this event was not a post fix failure of recall z-0825-2019.Because of the extensive damage done to the power supply board, a root cause could not be determined.

• 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: 16806368
• MDR Text Key: 313917262
• Report Number: 1516825-2023-00001
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 1061303186022
• UDI-Public: (01)1061303186022
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K122813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

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 Model Number: 400CE
• Device Catalogue Number: 86022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: 03/31/2023
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2017
• 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