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

Model Number 400CE

Device Problem Device Inoperable (1663)

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

Event Date 03/27/2017

Event Type  malfunction  

Manufacturer Narrative

Csz medical technical support received a complaint stating the hematherm pump was not working.The user facility had a backup device that allowed the procedure to continue successfully.Csz 3rd party technician (b)(6) found a loose connection between the f6 fuse and the fuse holder.The technician secured the fuse to resolve the issue.

Event Description

Cincinnati sub-zero medical technical support received a complaint stating the hematherm pump was not working.The user facility had a backup device and the procedure was able to continue.There was no patient or user injury reported.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: 6538239
• MDR Text Key: 74406861
• Report Number: 1516825-2017-00012
• 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: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• 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 Device Evaluated by Manufacturer?: Yes
• 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