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

Model Number MCH-1000(M)

Device Problems Fluid/Blood Leak (1250); Device Emits Odor (1425); Overheating of Device (1437)

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

Event Date 10/11/2021

Event Type  malfunction  

Manufacturer Narrative

Upon inspection of the device, the technician found that the device was leaking from the close nipple, and identified that the heater was nonfunctional and had burnt the heater chamber which was the source of the burning smell.The technician replaced the heater, heater chamber, close nipple and wet end kit.The technician then performed an inspection to ensure overall device functionality, for which it passed.Several possible failure modes were identified including the device being ran without water, lack of water circulation, a short circuit in the heater, or the user not priming the device.These modes of failure are reasonable for this to occur, however a conclusion is not able to be reached to determine the root cause of the failure.

Event Description

Customer reports that their device is overheating while in use and presented a burning smell.The issue was identified while the customer was setting up for a case, and was swapped out before the patient was in the room.

Event Description

Customer reports that their device is overheating while in use and presented a burning smell whil setting up for a case.The device was swapped out before the patient was in the room.

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 heater to be the source of the burning smell.All damaged components were replaced, the device passed final inspection, and it is fully functional.

Manufacturer Narrative

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

Event Description

Customer reports that their device is overheating while in use and presented a burning smell whil setting up for a case.The device was swapped out before the patient was in the room.

• 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: 12798379
• MDR Text Key: 281921540
• Report Number: 3007899424-2021-00042
• 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: Inspection
• 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

• 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: 10/14/2021
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/11/2021
• Supplement Dates Manufacturer Received: 10/11/2021; 10/11/2021
• Supplement Dates FDA Received: 07/20/2022; 09/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2016
• 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