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

Model Number MCH-1000(M)

Device Problem Overheating of Device (1437)

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

Event Date 09/21/2021

Event Type  malfunction  

Event Description

The device ran normally at 37 c , but when operated at 42c it went over the set point to 43.3 c after a few hours.The hoses were checked for kinks or clogs but none were found.It was noticed the motor impellar/pump was louder than usual.

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.

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 event although no patient information was communicated.Cardioquip could not reproduce the issues reported by the customer during investigation.It was determined that the device was not operated with cold water in the water tank for an extended period leading to an overtemp error.The device was inspected and is fully operational.

Event Description

The device ran normally at 37 c, but when operated at 42c it went over the set point to 43.3 c after a few hours.The hoses were checked for kinks or clogs but none were found.It was noticed the motor impellar/pump was louder than usual.

• Brand Name: CARDIQUIP 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: 12685978
• MDR Text Key: 280449347
• Report Number: 3007899424-2021-00032
• 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
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• 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 Manufacturer Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2015
• 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