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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM 400CE CARDIOPULMONARY BYPASS TEPERATURE CONTROLLER

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GENTHERM MEDICAL, LLC HEMOTHERM 400CE CARDIOPULMONARY BYPASS TEPERATURE CONTROLLER Back to Search Results
Model Number 400CE
Device Problem Unintended Collision (1429)
Patient Problems Cardiopulmonary Arrest (1765); Ventricular Fibrillation (2130)
Event Type  malfunction  
Manufacturer Narrative
Gentherm received a medwatch report (#mw5085957) (complaint (b)(4)), stating a staff member lead against the hemotherm device which inadvertently pressed the cool button causing the device to cool rapidly.
 
Event Description
Female being supported on ecmo. Staff member leaned against the hemotherm ce heater/cooler machine and hit cool button. No temperature parameters were set so machine cooled very rapidly and patient went into v-fib arrest. She was re-warmed and had rosc.
 
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Brand NameHEMOTHERM 400CE
Type of DeviceCARDIOPULMONARY BYPASS TEPERATURE CONTROLLER
Manufacturer (Section D)
GENTHERM MEDICAL, LLC
12011 mosteller
cincinnati OH 45241
Manufacturer (Section G)
GENTHERM MEDICAL, LLC
12011 mosteller
cincinnati OH 45241
Manufacturer Contact
christina miracle
12011 mosteller
cincinnati, OH 45241
8009897373
MDR Report Key8672848
MDR Text Key150887489
Report Number1516825-2019-00006
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
PMA/PMN Number
K122813
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 06/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/05/2019
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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