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

Model Number MCH-1000(M)

Device Problems Insufficient Heating (1287); Insufficient Information (3190)

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

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

Cardioquip is seeking patient information and the date the event occured.Upon receiving additional information from the completion of the investigation or the user facility, cardioquip will file supplementary reports.

Event Description

Customer reports that the device is not heating properly, and reports that the device overshoots it's delivery temperature while in use.During troubleshooting with the customer, they reported that the device was pulling roughly 2.6a in defrost mode, and would take about an hour to reach it's setpoint.

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 device is not heating properly, and reports that the device overshoots it's delivery temperature while in use.During troubleshooting with the customer, they reported that the device was pulling roughly 2.6a in defrost mode, and would take about an hour to reach it's setpoint.

• 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: 12485795
• MDR Text Key: 283504469
• Report Number: 3007899424-2021-00028
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• 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: 09/16/2021
• Is this an Adverse Event Report?: No
• 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: 09/07/2021
• Date Manufacturer Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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