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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(I)
Device Problems Fluid/Blood Leak (1250); Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/20/2022
Event Type  malfunction  
Event Description
The customer reported that the unit is leaking internally.Water also leaked into electrical components.There was smoking coming from inside the unit with a burnt smell.
 
Manufacturer Narrative
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 was run with insufficient water.This resulted in an air pocket remaining inside the heater chamber which led to the heaters dissipating heat incorrectly.This caused the device's components to burn and melt.Following an internal water path 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 Key15839015
MDR Text Key305539422
Report Number3007899424-2022-00160
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 11/21/2022
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(I)
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2015
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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