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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CINCINNATI SUB-ZERO PRODUCTS, INC. HEMOTHERM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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CINCINNATI SUB-ZERO PRODUCTS, INC. HEMOTHERM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 400CE
Device Problems Device Displays Incorrect Message (2591); No Flow (2991); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/23/2020
Event Type  Malfunction  
Event Description

While on cpb, heater cooler alarmed and stopped functioning. The right hand side of heater cooler (heat side) showed ee, instead of temperature and water was not flowing. I attempted a reboot resulting in the same error message. Water lines were quickly changed to a different to heater cooler.

 
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Brand NameHEMOTHERM
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
CINCINNATI SUB-ZERO PRODUCTS, INC.
12011 mosteller rd 3rd floor
blue ash OH 45241
MDR Report Key10013226
MDR Text Key189454198
Report Number10013226
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 03/24/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number400CE
Device Catalogue Number86022
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/24/2020
Event Location Hospital
Date Report TO Manufacturer04/30/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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