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

Model Number 400CE

Device Problems Device Displays Incorrect Message (2591); No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2020

Event Type  malfunction  

Manufacturer Narrative

Customer reported via medwatch report that the unit alarmed showing an ee error code and water was not flowing.No patient or user injury reported.

Event Description

While on cardiopulmonary bypass (cpb), the heater-cooler alarmed and stopped functioning.The right hand side of the heater-cooler (heat side) showed the "ee" error code instead of the temperature and the water was not flowing.A reboot was attempted and resulted in the same error message.Water lines were quickly changed to a different heater-cooler.No patient injury was reported.

• Brand Name: HEMOTHERM
• Type of Device: HEATER-COOLER
• Manufacturer (Section D): GENTHERM MEDICAL; 12011 mosteller road; cincinnati, oh
• Manufacturer (Section G): GENTHERM MEDICAL; 12011 mosteller road; cincinnati, oh
• Manufacturer Contact: christina miracle ; 12011 mosteller; cincinnati, oh ; 3265295
• MDR Report Key: 10110519
• MDR Text Key: 196077437
• Report Number: 1516825-2020-00005
• Device Sequence Number: 1
• Product Code: DWC
• 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: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/30/2020

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
• Device Operator: Health Professional
• Device Model Number: 400CE
• Device Catalogue Number: 86022
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 06/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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