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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CINCINNATI SUB-ZERO PRODUCTS, LLC / GENTHERM MEDICAL LLC HEMOTHERM HEATER / COOLER - DUAL RESERVOIR CONTROLLER TEMPERATURE CARDIOPULMONARY BYPASS

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CINCINNATI SUB-ZERO PRODUCTS, LLC / GENTHERM MEDICAL LLC HEMOTHERM HEATER / COOLER - DUAL RESERVOIR CONTROLLER TEMPERATURE CARDIOPULMONARY BYPASS Back to Search Results
Model Number 400CE
Device Problems Break (1069); Smoking (1585)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/26/2019
Event Type  Malfunction  
Event Description

During a cardiothoracic surgical procedure, the hemotherm, a heating / cooling device with hoses that connect to the warming blanket which is under the pt, was noted to be "smoking" from the front of the machine by the perfusionist. The device was immediately unplugged, disconnected from the warming blanket and removed from the surgery room. Biomedical engineering services found the "mother board" component within the hemotherm console to have been damaged.

 
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Brand NameHEMOTHERM HEATER / COOLER - DUAL RESERVOIR
Type of DeviceCONTROLLER TEMPERATURE CARDIOPULMONARY BYPASS
Manufacturer (Section D)
CINCINNATI SUB-ZERO PRODUCTS, LLC / GENTHERM MEDICAL LLC
12011 mosteller rd.
cincinnati OH 45241
MDR Report Key8515266
MDR Text Key142133927
Report NumberMW5085864
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 04/03/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/12/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number400CE
Device Catalogue Number86022
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/03/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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