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U.S. Department of Health and Human Services

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

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CINCINNATI SUB-ZERO HEMOTHERM 400 CE CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER Back to Search Results
Model Number 400CE
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/24/2018
Event Type  malfunction  
Manufacturer Narrative
Csz received a complaint stating the device displayed error ee03 during a procedure. The device was switched out and the procedure completed successfully. No patient harm or injury occurred. Csz technical support troubleshot the device with the facility. The cool side water temp sensor was found to be defective. The facility replaced the thermistor and the device functions as designed. The thermistor or was not shipped back for csz to investigate.
 
Event Description
Csz received a complaint stating the device displayed error ee03 during a procedure. The device was switched out and the procedure completed successfully. No patient harm or injury occurred. This report was filed in our complaint handling system as complaint #: (b)(4).
 
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Brand NameHEMOTHERM 400 CE
Type of DeviceCARDIOPULMONARY 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 Key7789788
MDR Text Key117434581
Report Number1516825-2018-00011
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122813
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number400CE
Device Catalogue Number86022
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/15/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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