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

Model Number MCH- 1000 (I)

Device Problems Alarm Not Visible (1022); Smoking (1585)

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

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

Due to user error and the low water level sensor not functioning as designed when a refrigeration module and an ice block are inside the tank, the device could be put in defrost mode without sufficient water.Thus, allowing the heating elements of the device to heat in a centralized area and damaging all internal components nearby.

Event Description

During quarterly disinfection of cardioquip modular cooler heater (mch).The mch began smoking and emitting a burning smell.No audible alarms or warning indicators occured.According to the service manual, "if the water level in the mch cold water tank falls below a safe operating level, the mch halts its operation, the low water level screen appears, and the alarm sounds a three-beep sequence every 8 seconds." this alarm was not triggered and did not occur.Per bmet, (b)(6): drained the mch, hit defrost mode, received temp differential error.The device was partially defrosted overnight.The next day, (b)(6) again placed mch in defrost mode (no water in device) and no temp diff error occurred this time.After 56 seconds, the ice block started defrosting quickly but then smoke started billowing out of the mch.Fire department had to be called.

Manufacturer Narrative

Further review determined that this is a non-reportable event.

Event Description

Customer reports smoke from device during defrost mode.

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.During the investigation, cardioquip identified the heaters to be the source of the smoke as they melted the heater chamber bushings.The water level sensor that stops the device from running did not trigger due to the presence of ice.Ice can block the sensor and cause it to not trigger.All damaged components were replaced, and the device passed final inspection, and is fully functional.

Event Description

Customer reports smoke from device during defrost mode.

• 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: 12485826
• MDR Text Key: 271865253
• Report Number: 3007899424-2021-00027
• 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: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCH- 1000 (I)
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/11/2021
• Date Manufacturer Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2019
• 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
• Patient Outcome(s): Required Intervention