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

Model Number MCH-1000(M)

Device Problems Insufficient Cooling (1130); Crack (1135); Smoking (1585); Material Deformation (2976)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

Upon inspection of the suspect device, it was found that the heating element failed, started overheating, and melted the adjacent pvc, resulting in the "smell of smoke" that the customer experienced.Through further investigation, it was determined that the heating element failed due to a degradation in the material, causing the heating element to not perform according to specifications.

Event Description

Customer reports that the unit started smelling like smoke while plugged into a power strip and during use on a patient.They also report that the unit will no longer cool.

Event Description

Customer reports that the unit started smelling like smoke while plugged into a power strip during use on a patient.They also report that the unit will no longer cool.

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.A patient was involved during the malfunction, but no information was given about the patient, or if the device affected the patient.During the investigation, cardioquip identified the heaters to be the source of the malfunction.The heaters failed due to degradation of the metal casing causing them to overheat, melt nearby pvc, and produce a smoking odor.The nonfunctioning components were replaced, and the device passed final inspection and is fully functional.

• 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: 10287191
• MDR Text Key: 202555182
• Report Number: 3007899424-2020-00005
• 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: Repair
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• 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
• Date Returned to Manufacturer: 06/22/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1