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

Model Number MCH-1000 (I)

Device Problems Electrical Shorting (2926); Fail-Safe Did Not Operate (4046)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/15/2019

Event Type  malfunction  

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.Upon investigating the device, cardioquip identified the water level sensor was incorrectly installed and the device had the incorrect serial on screen.The sensor was reinstalled, and the device was given the correct serial number for the screen.The device passed final inspection and is fully functional.

Event Description

Customer reports that upon unboxing the device, the unit skips the water level check portion of it's startup, and proceeds directly to self-test.The distributor inspecting the device did not add water to the device beforehand, and circulated both the main and cpg pump dry.The unit's screen began flashing, would stop function and restart the device, indicating a short of kind.

Event Description

Customer reports that upon unboxing the device, the unit skips the water level check portion of it's startup, and proceeds directly to self-test.The distributor inspecting the device did not add water to the device beforehand, and circulated both the main and cpg pump dry.The unit's screen began flashing, would stop function and restart the device, indicating a short of kind.

Manufacturer Narrative

Further review determined that this is a non-reportable event.

• 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: 15056443
• MDR Text Key: 304431664
• Report Number: 3007899424-2022-00068
• 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: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MCH-1000 (I)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1