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

Model Number MCH-1000(M)

Device Problems Fire (1245); Smoking (1585)

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

Event Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is pending.Suspect device has yet to be made available to cardioquip for evaluation.

Event Description

Customer reported smoke coming from the unit and pulled the fire alarm.The device was opened by the customer and they reported that there had been a "fire" around the heater chamber and heater, device's heaters are nonfunctional.

Manufacturer Narrative

The manufacturer is reporting the following complaint after a voluntary review of all complaints (reportable or not) since 2016.This report is being filed now, after being scrutinized under a newly revised risk matrix, recently adopted after inspection.The customer notified cardioquip that a patient was involved during the malfunction.It was communicated verbally to cardioquip, the patient had died during the case, but the death was not directly caused by the device's malfunction.No further patient information was provided.Cardioquip's investigation determined the heater was nonfunctional.Following replacement, the device passed inspection, and is fully operational.

Event Description

Customer reports that the device's heaters are nonfunctional due the wires of the heater becoming exposed and melting insulation surrounding the tank.The customer verbally told the technician that a patient was on the device, had died during the case, but that the patient's death was not directly caused by the device's malfunction.

• 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: 11163351
• MDR Text Key: 227863896
• Report Number: 3007899424-2021-00001
• 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: Biomedical Engineer
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2018
• 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): Death