MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM 400CE; CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER

Model Number 400CE

Device Problems Break (1069); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Gentherm received medwatch report #mw5085864 (complaint # (b)(4)) which stated the hemotherm device appeared to have smoke coming from the front of the device.Mdr investigation concluded the device was being used for treatment, no serious injury took place and the gentherm medical hemotherm device did fail to meet its specifications.

Event Description

From medwatch report: during a cardiothoracic surgical procedure, the hemotherm, a heating/cooling device with hoses that connect to the warming blanket which is under the pt.Was noted to be "smoking" from the front of the machine by the perfusionist.The device was immediately unplugged, disconnected from the warming blanket and removed from the surgery room.Biomedical engineering services found the "mother board" component within the hemotherm console to have been damaged.

Manufacturer Narrative

Device was returned and evaluated.The evaluation confirmed the customer had spilled water on the cpu and power boards.The boards were replaced to correct.

• Brand Name: HEMOTHERM 400CE
• Type of Device: CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller; cincinnati OH 45241
• Manufacturer (Section G): GENTHERM MEDICAL, LLC; 12011 mosteller; cincinnati OH 45241
• Manufacturer Contact: christina miracle ; 12011 mosteller; cincinnati, OH 45241 ; 8009897373
• MDR Report Key: 8672849
• MDR Text Key: 147169471
• Report Number: 1516825-2019-00007
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 10613031860221
• UDI-Public: (01)10613031860221
• Combination Product (y/n): N
• PMA/PMN Number: K122813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400CE
• Device Catalogue Number: 86022
• Date Manufacturer Received: 05/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2018
• 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