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

Model Number 86022

Device Problem Device Inoperable (1663)

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

Event Date 12/29/2016

Event Type  malfunction  

Manufacturer Narrative

Cincinnati sub-zero technical support recommended sending a technician to the account.The technician found the pump malfunctioning due to an inoperable power supply board.Per the csz service manual, the hemotherm must be serviced and/or preventive maintenance must be performed at specific intervals as outlined in the manual.Improper repair and inadequate maintenance can result in damage to the hemotherm system and patient injury.It is unknown if the facility performs preventative maintenance on their devices.The technician replaced the power supply board to resolve the issue.Based on this information, no further action is required.

Event Description

Cincinnati sub-zero received a report from the account stating the pump stopped working during re-warming.The device was located at the account.There was no patient/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 ; 5137729119
• MDR Report Key: 6316722
• MDR Text Key: 67332277
• Report Number: 1516825-2017-00001
• 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: Health Professional
• Type of Report: Initial
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 86022
• Device Catalogue Number: 400CE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2016
• 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