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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOQUIP, LLC CARDIOQUIP MODULAR COOLER-HEATER (MCH) CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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CARDIOQUIP, LLC CARDIOQUIP MODULAR COOLER-HEATER (MCH) CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number MCH-1000(I)
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bradycardia (1751); High Blood Pressure/ Hypertension (1908)
Event Date 01/07/2021
Event Type  Malfunction  
Event Description

Patient became bradycardic/hypertensive suddenly around 1430, it was found that the water heater on the ecmo circuit had been put onto standby unknowingly, upon discovering this it was restarted, patient was rewarmed slowly and bradycardia/ hypertension resolved.

 
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Brand NameCARDIOQUIP MODULAR COOLER-HEATER (MCH)
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
CARDIOQUIP, LLC
8422 calibration ct
college station TX 77845
MDR Report Key11863523
MDR Text Key251977020
Report Number11863523
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 04/19/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/21/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberMCH-1000(I)
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/19/2021
Event Location Hospital
Date Report TO Manufacturer05/21/2021
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 Unkown

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