MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM

Model Number 400CE

Device Problem Output Problem (3005)

Patient Problem Alteration in Body Temperature (4568)

Event Type  malfunction  

Manufacturer Narrative

Complaint #(b)(4) received.The customer concluded the heating element was not functioning.There were no allegations of patient harm.To date, the device has not returned for evaluation.

Event Description

The perfusionist had the patient on bypass and noticed temperature of the patient was low, the device set point was at 37 but the actual temperature was 32.The customer checked the flow indicator and it was showing forward flow.The device was changed out with blanketrol devices without incident.The hemotherm 400ce device was sent to biomed to help diagnose issue.Biomed determined the heating element was not functioning.

Manufacturer Narrative

The device was returned for evaluation on august 4, 2021.The customer issue was confirmed; the heater was defective.The heater was replaced to correct.

• Brand Name: HEMOTHERM
• Type of Device: HEMOTHERM
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller rd.; cincinnati OH 45241
• Manufacturer Contact: angie gegner ; 12011 mosteller rd; cincinnati, OH 45241
• MDR Report Key: 12170349
• MDR Text Key: 263462545
• Report Number: 1516825-2021-00008
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 10613031860221
• UDI-Public: (01)10613031860221
• Combination Product (y/n): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• 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
• Date Returned to Manufacturer: 08/04/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1