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U.S. Department of Health and Human Services

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

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CARDIOQUIP, LLC CARDIOQUIP MODULAR HEATER COOLER CARDIOPULMONARY BYPASS COOLER HEATER Back to Search Results
Model Number MCH-1000(M)
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Cardioquip is seeking patient information and the date the event occured. Upon receiving additional information from the completion of the investigation or the user facility, cardioquip will file supplementary reports.
 
Event Description
Customer reports that the device is not heating properly, and reports that the device overshoots it's delivery temperature while in use. During troubleshooting with the customer, they reported that the device was pulling roughly 2. 6a in defrost mode, and would take about an hour to reach it's setpoint.
 
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Brand NameCARDIOQUIP MODULAR HEATER COOLER
Type of DeviceCARDIOPULMONARY BYPASS COOLER HEATER
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 Key12485795
MDR Text Key283504469
Report Number3007899424-2021-00028
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 user facility
Reporter Occupation Other Health Care Professional
Remedial Action Repair
Type of Report Initial
Report Date 09/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMCH-1000(M)
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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