MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM

Model Number 400CE

Device Problem Filling Problem (1233)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Complaint (b)(4) received.After speaking with biomed, it was concluded that the issue was with the cool return solenoid.Perfusionist did not want to return the device to use until biomed could change the solenoid.Replacement part was sent to the customer.There were no allegations of patient harm.To date, no parts have returned for evaluation.

Event Description

Customer states that this hemotherm is continually having issues with the cool reservoir filling while heating and the heat reservoir emptying during procedures.

• 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: 12079577
• MDR Text Key: 267652192
• Report Number: 1516825-2021-00006
• 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: 06/28/2021

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 06/28/2021
• Supplement Dates Manufacturer Received: 06/03/2021
• Supplement Dates FDA Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1