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

Model Number MCH-1000(M)

Device Problems Overheating of Device (1437); Insufficient Information (3190); Excessive Heating (4030)

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

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

This device has not been received by cardioquip.Once the device has been received and the investigation has been completed, cardioquip will file supplementary reports.

Event Description

Customer reports that their device is overheating while on patients after adding ice and changing water in the tank periodically.

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 although no patient information was communicated.Cardioquip's investigation determined that the device is fully operational.

Event Description

Customer reports that their device is overheating while on patients after adding ice and changing water in the tank periodically.

• Brand Name: CARDIOQUIP MODULAR HEATER COOLER
• Type of Device: CARDIOPULMONARY BYPASS COOLER HEATER
• 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: 12740168
• MDR Text Key: 283301421
• Report Number: 3007899424-2021-00033
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• 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: 11/02/2021
• 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: 08/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2019
• 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