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

Model Number MCH-1000(M)

Device Problems Insufficient Heating (1287); Temperature Problem (3022); Insufficient Information (3190)

Patient Problems Alteration in Body Temperature (4568); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2020

Event Type  malfunction  

Event Description

The extracorporeal membrane oxygenation (ecmo) heater clicked into test mode during cannulation.Water was added, and seemed to be functioning appropriately at that time.About an hour later, it was noted that the heater temperature was 30 degrees celsius, and the patient's temperature decreased.The heater was exchanged with another, and sent to our biomedical engineering team to investigate.

Event Description

User facility report number: 0533020000-2020-8007.

Manufacturer Narrative

First, cardioquip worked with the user facility, by phone and email, in an attempt to replicate the issue that was initially reported.In working with the user facility personnel, they could not replicate the problem as reported.A cardioquip technician went to the user facility to inspect the device, once onsite the issue still could not be replicated.In performing the final inspection there were loose wires found.It is not clear whether this would have caused the event that was reported.The device was brought back into specification and passed a final inspection.

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 ac power supply and a solid-state relay contained loose wiring.Following securement of the wires, the device passed inspection and is fully operational.

Event Description

Customer reports a patients temperature decreased when ecmo heater went into standby 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: 10591352
• MDR Text Key: 208740953
• Report Number: 3007899424-2020-00008
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2020
• Is this an Adverse Event Report?: Yes
• 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: 09/22/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2018
• 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): Life Threatening