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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOQUIP CARDIOQUIP HEATER/COOLER MACHINES CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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CARDIOQUIP CARDIOQUIP HEATER/COOLER MACHINES CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number MCH-1000(I)
Device Problems Image Display Error/Artifact (1304); Mechanical Problem (1384); Temperature Problem (3022); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 06/07/2021
Event Type  Injury  
Event Description

Our hospital purchased two cardioquip mch-1000(i) heater/cooler machines to use in our cardiac surgery practice. We have been having consistent issues with malfunctions of the machines since purchase. On (b)(6) 2021, both of the machines malfunctioned. One of the malfunctions was that the control screen froze and we were no longer able to control it. This happened while we were on cardiopulmonary bypass. They machine had to be restarted several times before it would work again. During the startup process, the heater/cooler machine dropped the temperature of our bypass circuit to 25 c which could of caused cardiac fibrillation among other potential issues. I believe the temperature drop is part of the startup process of the machine which i was unaware of at the time. However, the initial freezing of the control screen is what caused the need to restart. The control screen froze again shortly after and we were again unable to control patient temperature. Fortunately, we were able to finish the procedure without harm but we came dangerously close. We have had multiple malfunctions of the machine in the one year that we have owned it and the company has been unable to find the source of the problems. Previous malfunctions have occurred and patient harm was averted only due to clinician vigilance and intervention. The machines have failed on several occasions to circulate cold water through the cardioplegia channel which is used to control the temperature of the patient's heart. The machine has also failed to maintain a stable set point on the hot water tank which is used to control the patient's body temperature. Fda safety report id # (b)(4).

 
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Brand NameCARDIOQUIP HEATER/COOLER MACHINES
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
CARDIOQUIP
TX
MDR Report Key11975719
MDR Text Key255764269
Report NumberMW5101806
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 06/08/2021
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received06/09/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMCH-1000(I)
Was Device Available For Evaluation? Yes
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

Patient TREATMENT DATA
Date Received: 06/09/2021 Patient Sequence Number: 1
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