MAUDE Adverse Event Report: CARDIOQUIP CARDIOQUIP HEATER/COOLER MACHINES; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number MCH-1000(I)

Device Problems Image Display Error/Artifact (1304); Mechanical Problem (1384); Temperature Problem (3022); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 06/07/2021

Event Type  Injury  

Event Description

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 (b)(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 # (b)(4).

• Brand Name: CARDIOQUIP HEATER/COOLER MACHINES
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIOQUIP; TX
• MDR Report Key: 11975719
• MDR Text Key: 255764269
• Report Number: MW5101806
• Device Sequence Number: 1
• Product Code: DWC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2021
• 2 Devices were Involved in the Event: 1 2

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention