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

Model Number MCH-1000(I)

Device Problems Insufficient Cooling (1130); Key or Button Unresponsive/not Working (4063)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2021

Event Type  malfunction  

Manufacturer Narrative

Customer communicated that the screen to operate the machine was unresponsive.Cardioquip personnel were given access to test the device and could not recreate the issue.The engineer suspects that the operator did not fully seat the connector plug.Customer communicated that, when the device was restarted, the water temperature would drop to 25 degrees celsius.The drop is caused by the normal startup self-test of the device.The screen can be removed and replaced during device operation, without interrupting temperature control; however, the customer was not aware of this functionality.In review of the labeling provided to the customer, in the form of the ifu, it is not made clear to the user that this functionality exists.

Event Description

Customer submitted a medwatch mw5101806 voluntary on 10-jun-2021 12:44:13.00: the was received by cardioquip on june 28, 2021.The medwatch stated the following.Our hospital purchased two cardioquip mch-1000(i) heater/cooler machines to use in our cardiac surgery practice.We have been having consistent issues with malfunctions of the machines since purchase.On (8)(6) 2021, both of the machines malfunctioned.One of the malfunctions was that the control screen froze and we were no longer able to control it.This happened while we were on cardiopulmonary bypass.They machine had to be restarted several times before it would work again.During the startup process, the heater/cooler machine dropped the temperature of our bypass circuit to 25 c which could of caused cardiac fibrillation among other potential issues.I believe the temperature drop is part of the startup process of the machine which i was unaware of at the time.However, the initial freezing of the control screen is what caused the need to restart.The control screen froze again shortly after and we were again unable to control patient temperature.Fortunately, we were able to finish the procedure without harm but we came dangerously close.We have had multiple malfunctions of the machine in the one year that we have owned it and the company has been unable to find the source of the problems.Previous malfunctions have occurred and patient harm was averted only due to clinician vigilance and intervention.The machines have failed on several occasions to circulate cold water through the cardioplegia channel which is used to control the temperature of the patient's heart.The machine has also failed to maintain a stable set point on the hot water tank which is used to control the patient's body temperature.Fda safety report id# (8)(4).

Event Description

Customer reports device is experiencing temperature fluctuation issues.

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 check valve was nonfunctional.Following the repair, the device passed inspection, and is fully operational.

• 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 Key: 12204130
• MDR Text Key: 280812684
• Report Number: 3007899424-2021-00011
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102147
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

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 Number: MCH-1000(I)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2021
• Initial Date FDA Received: 07/21/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention