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

Model Number	400CE
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint #(b)(4) received.There were no allegations of patient harm.The customer did not return the device for evaluation.
Event or Problem Description
Customer reports: "we had an issue with one of our hemotherm (b)(4) units (s/n (b)(6), va biomed ee 194-11307ce) yesterday during our case.Upon rewarming the patient/unit, the warm side would not go above 34 degrees.We switched out units to continue rewarming our patient.There was not any alarm on the affected unit.".
Additional Manufacturer Narrative
Udi related data quality updates only: udi information in section d of original submission is incorrect.

• Brand Name: HEMOTHERM
• Common Device Name: 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: 18090867
• Report Number: 1516825-2023-00007
• Device Sequence Number: 12233383
• Product Code: DWC
• UDI-Device Identifier: 10613031860221
• UDI-Public: 10613031860221
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K122813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown