MAUDE Adverse Event Report: CINCINNATI SUB-ZERO 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 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

The user facility contacted csz technical support for troubleshooting.Troubleshooting confirmed a blown fuse on the power supply board.The facility replaced the defective power supply board and tested the device.The unit now functions as designed.No patient harm or injury occured.

Event Description

Csz received a medwatch stating during rewarming of a patient the unit was not functioning correctly.The device was switched out which caused a delay.The rewarming was completed successfully and no patient harm or injury occurred.This report is filed in our complaint handling system as (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: 7621567
• MDR Text Key: 111890677
• Report Number: 1516825-2018-00007
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• 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
• Date Manufacturer Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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