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

Model Number MCH-1000(M)

Device Problem Smoking (1585)

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

Event Date 12/06/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation found that the damage to the device was due to the device not being primed before use.The heater chamber has a distinct line separating undamaged pvc and melted and charred pvc, indicating that water was only present in half of the heater chamber.This suggests that there was air left in the heater chamber.The air in the heater chamber affected the heaters ability to evenly transfer heat.This led to the heater chamber temperature to be much higher than intended, melting the surrounding pvc, and causing the smoke observed by the user.In order to repair the devices smoke damage, cardioquip recommended an internal water pathway replacement be performed.Cardioquip has completed this repair, and the device has been returned to specification and full functionality.The customer has also been reminded of the importance of running a full prime cycle, with all hoses and accessories attached, before using the device during a case.

Event Description

The device was on an ecmo case when the temperature of the unit suddenly "ramped up" (increased).Unit started smoking.Tank is brown.The issue was discovered by (b)(6), device was on a patient and to his knowledge, there was no patient harm.Depot service is required.

• 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: 18655331
• MDR Text Key: 334839169
• Report Number: 3007899424-2024-00004
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCH-1000(M)
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2017
• 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