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 Consequences Or Impact To Patient (2199)

Event Date 03/24/2017

Event Type  malfunction  

Manufacturer Narrative

Csz medical technical support received a complaint stating the hemotherm membrane was not working.The user facility had a backup device and there was no delay in surgery.Csz 3rd party technician (b)(4) arrived at the user facility and replaced the membrane on the device to resolve the issue.The replaced membrane was returned to csz for inspection and no problem was found.Investigation is ongoing.

Event Description

Cincinnati sub-zero medical technical support received a complaint stating the hemotherm membrane was not working.The user facility had a backup device and the procedure was not delayed.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: 6522659
• MDR Text Key: 74149795
• Report Number: 1516825-2017-00009
• 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: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2017
• 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