MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM

Model Number	400CE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint# (b)(4) received.There were no allegations of patient harm.Device has not yet returned for evaluation.
Event or Problem Description
Customer claims their hemotherm 400ce was not flowing and froze up during a procedure; "the perfusionist had been running it on the hot side of the device for a case and when it was time to switch it over to the cold side, the device started alarming.It was then they noticed the coil had iced up and the water was not flowing." a second device was used to finish out the case, no claim of injury to the patient.
Additional Manufacturer Narrative
Device was returned for evaluation on august 6, 2021.The evaluation was unable to confirm the issue; no problem found.

• Brand Name: HEMOTHERM
• Common Device Name: 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: 12170340
• Report Number: 1516825-2021-00007
• Device Sequence Number: 14492621
• Product Code: DWC
• UDI-Device Identifier: 10613031860221
• UDI-Public: (01)10613031860221
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2021

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown