MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM; HEATER/COOLER

Model Number	400CE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During surgery the machine heated the water to 42°c, but when the perfusionist turned on the pump, the heater turned off and it never turn on again.The temperature dropped to 30°c but the setpoint was in 42°c.Later, they checked the machine and when turned on the pump in the heater mode, the machine did not heat the water.But if they stop the pump, the heater started to heat.No adverse event reported.
Event or Problem Description
During surgery the machine heated the water to 42°c, but when the perfusionist turned on the pump, the heater turned off and it never turn on again.The temperature dropped to 30°c but the setpoint was in 42°c.Later, they checked the machine and when turned on the pump in the heater mode, the machine did not heat the water.But if they stop the pump, the heater started to heat.No adverse event reported.

• Brand Name: HEMOTHERM
• Common Device Name: HEATER/COOLER
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller road; cincinnati OH 45241
• MDR Report Key: 11373254
• Report Number: 1516825-2021-00002
• Device Sequence Number: 3382382
• Product Code: DWC
• UDI-Device Identifier: 10613031860221
• UDI-Public: (01)10613031860221
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

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
• Operator of Device: No Information
• Device Model Number: 400CE
• Device Catalogue Number: 86022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1