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

Model Number MCH-1000(M)

Device Problems Excessive Cooling (2932); Activation Problem (4042)

Patient Problems Abdominal Pain (1685); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/07/2019

Event Type  malfunction  

Manufacturer Narrative

An investigation was conducted on the mch-1000(m), where it was noted that the device had not been serviced by a cardioquip certified technician in over 2 years.Upon inspection, it was discovered, through the use of an electrical safety analyzer, that the leakage current tested over 100[?]a and that the 1600w heater was shorting internally to its chassis, which caused the "main heater" failure alarm.After speaking with the ecmo coordinator, she was not able to definitively identify that the cardioquip mch-1000(m) caused the patients discomfort.She believed that the delivery of colder water to the patient might have caused the abdominal discomfort.The 1600w heater was replaced, and the mch-1000(m) passed a full inspection.

Event Description

Ecmo coordinator reported a "heater failure" alert on the start-up screen.However, the unit had been in standby mode and was connected to an ecmo circuit at the time.When the clinician pressed "run" on the cardioquip, it went into "system test" and resulted in the "heater failure" alarm.Also, the patient reported sharp pain in the abdomen.The clinician stated that while in standby, the water would have cooled to room temperature and the delivery of the colder water to the patient caused the sharp pain in the abdomen of the patient which resulted in the discomfort.The clinician ultimately swapped out the unit.

Event Description

Customer reports that the unit goes to back to "standby" mode after being put into run mode during a case.The customer attempted to run the unit multiple times afterwards, each time running only for one minute or less before going back into standby mode.

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.The issue was unable to be replicated during investigation.Although unrelated to the issue described by the customer, cardioquip identified the 1600w heater as requiring replacement.Following replacement, the device passed inspection and is fully operational.

• 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: 8958001
• MDR Text Key: 190684605
• Report Number: 3007899424-2019-00003
• 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: Repair
• Type of Report: Initial,Followup
• Report Date: 10/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• 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: 08/06/2019
• Date Manufacturer Received: 08/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2018
• 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