MAUDE Adverse Event Report: CINCINNATI SUB-ZERO HEMOTHERM 400 CE; CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER

Model Number 400CE

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2018

Event Type  malfunction  

Manufacturer Narrative

Csz received a complaint stating the device displayed error ee03 during a procedure.The device was switched out and the procedure completed successfully.No patient harm or injury occurred.Csz technical support troubleshot the device with the facility.The cool side water temp sensor was found to be defective.The facility replaced the thermistor and the device functions as designed.The thermistor or was not shipped back for csz to investigate.

Event Description

Csz received a complaint stating the device displayed error ee03 during a procedure.The device was switched out and the procedure completed successfully.No patient harm or injury occurred.This report was filed in our complaint handling system as complaint #: (b)(4).

• Brand Name: HEMOTHERM 400 CE
• Type of Device: CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER
• Manufacturer (Section D): CINCINNATI SUB-ZERO; 12011 mosteller road; cincinnati OH 45241
• Manufacturer Contact: christina miracle ; 12011 mosteller road; cincinnati, OH 45241
• MDR Report Key: 7789788
• MDR Text Key: 117434581
• Report Number: 1516825-2018-00011
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• 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: 86022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2016
• 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