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

Model Number MCH-1000(R)

Device Problem Smoking (1585)

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

Event Date 11/17/2021

Event Type  malfunction  

Manufacturer Narrative

At this time cardioquip has not received this device for inspection.Once the investigation has been completed, additional reports will be filed.

Event Description

Customer reports via phone call that this refrigeration module produced smoke and stopped working while in use on a patient.The device was swapped out for a replacement and the incident did not negatively impact the patient's health.Customer reports that their device is overheating while in use on a patient, at which point the device was swapped out and replaced with a backup device.The customer states that this issue did not impact the patient's health negatively.

Manufacturer Narrative

The customer notified cardioquip that a patient was involved during the malfunction, but there was no injury as a result and no information about the patient was given.Cardioquip's investigation was inconclusive as the issue could not be replicated or show any evidence of damaged components in the device.The device passed all inspection tests and is fully functional.

Event Description

Customer reports this refrigeration module produced smoke and stopped working while in use on a patient, the device was swapped out for a replacement and the incident did not negatively impact the patient's health.

• 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: 12972672
• MDR Text Key: 282029748
• Report Number: 3007899424-2021-00047
• 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: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCH-1000(R)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2021
• 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