MAUDE Adverse Event Report: HEMOTHERM 400CE; CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER

Model Number 400CE

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 08/14/2018

Event Type  malfunction  

Manufacturer Narrative

Csz received complaint (b)(4) indicating the device displayed the ee02 error code during a procedure.The ee02 error code informs the user of a heat thermistor discrepancy.The unit was swapped out and the procedure was completed.No patient harm or injury occurred.

Event Description

Csz received a complaint that the hemotherm device displayed the ee02 error code during a procedure.

Manufacturer Narrative

The device was not returned for evaluation.The customer was able to reset the alarm code, ee02, to correct.Root cause is unknown.

• Brand Name: HEMOTHERM 400CE
• Type of Device: CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER
• MDR Report Key: 7866623
• MDR Text Key: 120120007
• Report Number: 1516825-2018-00013
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K122813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• 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: 400CE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1