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

Model Number MCH-1000(I)

Device Problem Smoking (1585)

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

Event Date 03/15/2023

Event Type  malfunction  

Manufacturer Narrative

A customer notified cardioquip service, via email, of a device that produced smoke during setup on (b)(6) 2023 and requested that the device receive service.Cardioquip responded to the customer and provided a packaging crate to the facility in order for the device to be shipped to cardioquip for investigation and potential repair.As of the date of this report, the investigation is ongoing and cardioquip is waiting to receive the device.

Event Description

The customer reported that this device produced smoke and a burning smell during setup.They turned the unit on and the unit stopped running soon after with a very noticeable smell of burning.They lifted the lid of the tank and smoke came billowing out as well as debris in the water.They did not see any type of fire/smoke damage, but it definitely has a very distinct, putrid burning rubber smell.

Manufacturer Narrative

Cardioquip received the device and completed an investigation.The investigation concluded that the customer did not fully prime the device prior to normal operation.Due to the smoke damage, the device was repaired via an internal water pathway replacement.Following the repair, the device passed inspection and is fully functional.

Event Description

The customer reported that this device produced smoke and a burning smell during setup.They turned the unit on and the unit stopped running soon after with a very noticeable smell of burning.They lifted the lid of the tank and smoke came billowing out as well as debris in the water.They did not see any type of fire/smoke damage, but it definitely has a very distinct, putrid burning rubber smell.

• 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: 16745399
• MDR Text Key: 313349171
• Report Number: 3007899424-2023-00110
• 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,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MCH-1000(I)
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2021
• 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