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

Model Number 400CE

Device Problems Insufficient Heating (1287); Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2021

Event Type  malfunction  

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 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
• Type of Device: HEATER/COOLER
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller road; cincinnati OH 45241
• Manufacturer Contact: jodi fischesser ; 12011 mosteller road; cincinnati, OH 45241 ; 5133265237
• MDR Report Key: 11373254
• MDR Text Key: 244396928
• Report Number: 1516825-2021-00002
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 400CE
• Device Catalogue Number: 86022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1