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

Model Number	400CE
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer reported device showed error code "ee" on the heat side.No adverse event reported.
Event or Problem Description
Customer states that while on cardiopulmanary bypass (cbp), heater cooler alarmed and stopped functioning.The right hand side of heater cooler (heat side) showed "ee" instead of temperature, and water was not flowing.User attempted a reboot resulting in the same error message.Waterlines were quickly changed to a different cooler.No adverse event reported.

• Brand Name: HEMOTHERM
• Common Device Name: HEATER/COOLER
• Manufacturer (Section D): GENTHERM MEDICAL; 12011 mosteller road; cincinnati, oh
• MDR Report Key: 10110414
• Report Number: 1516825-2020-00006
• Device Sequence Number: 11494259
• Product Code: DWC
• UDI-Device Identifier: 10613031860221
• UDI-Public: (01)10613031860221
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/02/2020

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: Health Professional
• Device Model Number: 400CE
• Device Catalogue Number: 86022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1