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

Model Number MCH-1000(I)

Device Problems Fluid/Blood Leak (1250); Overheating of Device (1437); Smoking (1585)

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

Event Date 10/15/2021

Event Type  malfunction  

Manufacturer Narrative

Upon inspection of the device, the technician found that the 600w heater had melted the heater chamber and caused smoke damage to the 90 degree pvc coupler and the check valve of the heater chamber.The technician replaced both heaters with two 800w heaters, the heater chamber, the 90 degree pvc coupler and check valve of the heater chamber, and then installed a 3rd check valve which the device was missing.The technician then performed an inspection to ensure overall device functionality, for which it passed.

Event Description

Customer reports that their unit is causing an electrical/burning smell.The hospital biomed confirmed that the unit has a burning smell.After opening the side panel, he discovered a leak from an unknown source.There were no errors on the screen.

Manufacturer Narrative

The investigation found the probable root cause to be the water level sensor not causing the system to alarm and alert the user there was not a enough water in the unit to allow proper operation.

Event Description

Customer reports electrical burning smell.

Manufacturer Narrative

Cardioquip's investigation determined the heaters to be the source of the issue.After replacing the heaters and the heater chamber, the device passed inspection, and is fully operational.

Event Description

Customer reports electrical burning smell.

Manufacturer Narrative

Further review determined that this is a non-reportable event.

• Brand Name: CARDIOQUIP MODULAR HEATER COOLER
• Type of Device: CARDIOPULMONARY BYPASS DEVICE
• Manufacturer (Section D): CARDIOQUIP, LLC; 8422 calibration ct.; college station, tx 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: 12807293
• MDR Text Key: 285411370
• Report Number: 3007899424-2021-00045
• 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: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MCH-1000(I)
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2016
• 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