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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 Problems Circuit Failure (1089); Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/20/2021
Event Type  malfunction  
Event Description
Customer reports that their device is failing the cooling portion of the self-test while in use on patients.Upon follow-up by cq service, the customer had the device on a patient and stated that the device was working as intended at that time.
 
Manufacturer Narrative
Cardioquip has reached out to (b)(6) medical center multiple times regarding receiving the device for an investigation and repair.Because the device is still in use on a patient, they are unable to send it to cardioquip.If the device is received, or any additional information is made available, cardioquip will file additional reports.
 
Event Description
Customer reports that their device is failing the cooling portion of the self-test while in use on patients.Upon follow-up by cq service, the customer had the device on a patient and stated that the device was working as intended at that time.
 
Manufacturer Narrative
The manufacturer is reporting the following complaint after a voluntary review of all complaints (reportable or not) since 2016.This report is being filed now, after being scrutinized under a newly revised risk matrix, recently adopted after inspection.The customer notified cardioquip that a patient was involved during the malfunction although no patient information was communicated.Cardioquip's investigation determined that the device malfunction described by the customer could not be replicated; however, the cooling valve relay was replaced to mitigate future device malfunction.Following replacement, the device passed inspection, and is fully operational.
 
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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 Key12763448
MDR Text Key283303467
Report Number3007899424-2021-00038
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 Health Professional,User Facility
Reporter Occupation Nurse
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 10/12/2022
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? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/20/2021
Initial Date FDA Received11/07/2021
Supplement Dates Manufacturer Received08/20/2021
Supplement Dates FDA Received10/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2020
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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