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 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

Csz received a complaint stating during a case the device set off the current leakage alarm.The case was completed successfully and no patient harm or injury occurred.Csz technical support had the user facility biomed disconnect the heater and run the unit checking for the current leakage.The user facility confirmed current leakage and found the heater to be defective.The facility replaced the heater and the devices functions as designed.

Event Description

Csz received a complaint stating during a case the device set off the current leakage alarm.Biomed brought the unit back to the shop and verified the current leakage.The case was completed successfully and no patient harm or injury occurred.The 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; 12011 mosteller road; cincinnati OH 45241
• Manufacturer Contact: christina miracle ; 12011 mosteller road; cincinnati, OH 45241
• MDR Report Key: 7538718
• MDR Text Key: 109255512
• Report Number: 1516825-2018-00004
• 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: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2016
• 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