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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 Contamination (1120); Microbial Contamination of Device (2303); Excessive Heating (4030)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/22/2021
Event Type  malfunction  
Manufacturer Narrative
Upon visual inspection of the device, while on-site at cardioquip, there was yellow colored growth within the tubing consistent with bacterial biofilm growth.The overall appearance, of the internal tubing, indicates a high probability of being contaminated with bacteria over the design specification.This is based on testing performed on devices similar in appearance.The problem with overtemping is found to be an issue within the software version that was on the device at the time of the complaint.The software was rolled back to a stable, functioning version.A design change addressing software issues is in the process of being implemented.
 
Event Description
Customer reports that their device is overheating while in use on a patient, at which point the device was swapped out and replaced with a backup device.The customer states that this issue did not impact the patient's health negatively.Upon visual inspection of the device, while on-site at cardioquip, there was yellow colored growth within the tubing consistent with bacterial biofilm growth.
 
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 while the device was being inspected at cardioquip, it was found to contain yellow-colored growth within the internal tubing that is typically consistent with bacterial contamination.The device was tested and found to contain bacterial contamination levels that exceeded acceptable limits.The device went through an internal water pathway replacement and was tested afterwards.According to lab results, the cfu count was within the acceptable limits.
 
Event Description
Upon visual inspection of the device, while on-site at cardioquip, there was yellow colored growth within the tubing consistent with bacterial biofilm growth.The overall appearance, of the internal tubing, had a high probability of being contaminated with bacteria passed the design specifications of >500 cfu/ml.This is based on testing performed on devices similar in appearance.
 
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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 Key12929641
MDR Text Key284287160
Report Number3007899424-2021-00046
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 Biomedical Engineer
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 06/03/2022
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 Model NumberMCH-1000(M)
Was Device Available for Evaluation? No
Date Returned to Manufacturer11/01/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/22/2021
Initial Date FDA Received12/03/2021
Supplement Dates Manufacturer Received10/22/2021
Supplement Dates FDA Received06/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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