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

Model Number MCH-1000(M)

Device Problems Insufficient Heating (1287); Naturally Worn (2988); Insufficient Information (3190)

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

Event Date 07/22/2020

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.

Manufacturer Narrative

Upon inspection of the device, it was found that the insulation around the wires of the 1600w heater was compromised, allowing the wires to become exposed.The exposed wires made contact with the chassis of the device, thus causing an electrical short to occur which cycled power to the device.This event returns the device to self-test mode, as described by the user.The device was repaired, and passed a full inspection.The cause of the compromised insulation around the 1600w heaters was addressed in manufacturing.

Event Description

User facility report number: (b)(4).

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 heater was nonfunctional.Following replacement, the device passed inspection, and is fully operational.

Event Description

Customer reports that the unit's delivery temperature suddenly dropped while on a patient, and that the unit suddenly cycled power.When running the unit overnight, the temperature went over the set temp.

• 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: 10591355
• MDR Text Key: 208753299
• Report Number: 3007899424-2020-00007
• 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: 10/12/2022

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: Other
• Device Model Number: MCH-1000(M)
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/12/2020
• Date Manufacturer Received: 08/14/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening