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

Model Number MCH-1000(I)

Device Problems Fluid/Blood Leak (1250); Smoking (1585)

Patient Problem Insufficient Information (4580)

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

Cardioquip technician arrived at the hospital of the (b)(6) and spoke with perfusionists (b)(6).(b)(6) stated that he believes the unit was filled with ice but not water.Other observations from the hospital include soot and grime covered ice, and soot buildup around the device.Cardioquip identified that the water leaked from the melted heater chamber which was burnt and covered in soot.He also noted that soot and biofilm were along connection points in the water path and that the water was yellow with a bad odor.It was also noted that the water level sensor was functioning properly but that it could have not alarmed due to high levels of ice.Due to initial findings, the device is being sent to cardioquip for further investigation.Upon completion of the investigation or receipt additional information, a follow up report will be filled.

Event Description

8/11/2021 received user facility report # (b)(4) and only states in "cardioquip began to smoke while rewarming the patient".(b)(6) 2021 customer reports that their device started producing smoke during a case, and that they found that the device was also leaking but are not sure of the location of the leak or whether or not the leak was the cause of the issue.

• Brand Name: CARDIOQUIP MODULAR COOLER HEATER
• Type of Device: CARDIOPULMONARY BYPASS COOLER HEATER
• 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: 12457094
• MDR Text Key: 270985497
• Report Number: 3007899424-2021-00025
• 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: user facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• 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
• Date Manufacturer Received: 08/03/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR