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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOQUIP, LLC CARDIOQUIP MODULAR COOLER HEATER; CARDIOPULMONARY BYPASS DEVICE

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CARDIOQUIP, LLC CARDIOQUIP MODULAR COOLER HEATER; CARDIOPULMONARY BYPASS DEVICE Back to Search Results
Model Number MCH-1000(M)
Device Problem Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2023
Event Type  malfunction  
Manufacturer Narrative
An investigation found that the damage to the device was due to the device not being primed before use.The heater chamber has a distinct line separating undamaged pvc and melted and charred pvc, indicating that water was only present in half of the heater chamber.This suggests that there was air left in the heater chamber.The air in the heater chamber affected the heaters ability to evenly transfer heat.This led to the heater chamber temperature to be much higher than intended, melting the surrounding pvc, and causing the smoke observed by the user.In order to repair the devices smoke damage, cardioquip recommended an internal water pathway replacement be performed.Cardioquip has completed this repair, and the device has been returned to specification and full functionality.The customer has also been reminded of the importance of running a full prime cycle, with all hoses and accessories attached, before using the device during a case.
 
Event Description
The device was on an ecmo case when the temperature of the unit suddenly "ramped up" (increased).Unit started smoking.Tank is brown.The issue was discovered by (b)(6), device was on a patient and to his knowledge, there was no patient harm.Depot service is required.
 
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Brand Name
CARDIOQUIP MODULAR COOLER HEATER
Type of Device
CARDIOPULMONARY BYPASS DEVICE
Manufacturer (Section D)
CARDIOQUIP, LLC
8422 calibration ct.
college station TX 77845
Manufacturer (Section G)
CARDIOQUIP, LLC
8422 calibration ct.
college station TX 77845
Manufacturer Contact
charley ford
8422 calibration ct.
college station, TX 77845
9796910202
MDR Report Key18655331
MDR Text Key334839169
Report Number3007899424-2024-00004
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102147
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Remedial Action Inspection
Type of Report Initial
Report Date 02/06/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMCH-1000(M)
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/06/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/24/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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