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

Model Number MCH-1000 (M)

Device Problems Overheating of Device (1437); Smoking (1585)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

The unit was received at cardioquip for investigation.Cardioquip tested the unit for basic functionality.Closer inspection of the heater chamber indicated oily, sooty, burn residue from the melted cpvc.The heater also showed signs of pitting, indicating bleach related damage.Smoke residue in the heater chamber was found, showing the device was run with air in the heater chamber causing it to overheat and melt the cpvc bushing.Air in the water circuit is eliminated through the cold water tank during priming.Under normal use in a cpb procedure, the device is initially used to cool the patient, so priming will occur naturally even if the operator did not execute the "prime" function.However, if priming is not performed and the device is immediately used for heating rather than cooling, an air pocket can form in the heater chamber.This indicates that the operator failed to prime the water circuit per the ifu "normal operation" section, leaving significant air in the heater chamber causing the cartridge heater to overheat and melt the cpvc bushing creating oily smoke.Cardioquip is working to confirm the date of the event with the user facility.Upon receiving any additional information, cardioquip will file supplementary reports.

Event Description

The customer reports that their device is producing smoke while in use on a patient, and suspects that the pump may be the source upon inspecting the device's internals.

Event Description

Customer reports device smoking while in use.

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.Cardioquip was notified by the customer that there was patient involvement during the malfunction, although no information identifying the patient was provided.Upon initial inspection, cardioquip identified a plastic bushing on the heater chamber as the source of the smoke.After further investigation, it was determined that the device was not primed before it was used in the case.Because air was not evacuated from the heater chamber through a priming cycle, the heater overheated the chamber causing it to smoke.After the damaged components were replaced, the device passed inspection and is fully operational.

• 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: 12457102
• MDR Text Key: 270983156
• Report Number: 3007899424-2021-00026
• 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: Inspection
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 08/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 09/10/2021
• Supplement Dates Manufacturer Received: 08/11/2021
• Supplement Dates FDA Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2015
• 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