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

Model Number 400CE

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

Csz medical technical support received an email stating the device went down during a procedure.The device was switched out and the procedure finished successfully.No patient harm or injury occurred.(b)(4), a csz 3rd party technician, found the power board and membrane needed to be replaced.The (b)(4) technician replaced the power board and membrane.The device was tested and functions as designed.

Event Description

Csz received an email stating the device went down during a procedure.The device was switched out and the procedure finished 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, LLC.; 12011 mosteller road; cincinnati OH 45241
• Manufacturer Contact: christina miracle ; 12011 mosteller road; cincinnati, OH 45241
• MDR Report Key: 7174963
• MDR Text Key: 97490788
• Report Number: 1516825-2018-00001
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2016
• 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