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

Model Number MCH-1000(I)

Device Problem Microbial Contamination of Device (2303)

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

Event Date 12/04/2023

Event Type  malfunction  

Event Description

Lab results ( (b)(6) 2023): sn (b)(6)> 1146000 mpn/ml (above acceptable limit).To remediate the device contamination, the customer either proceed with an internal water path replacement procedure or a trade-in program.

Manufacturer Narrative

Following test results outside of cardioquip specifications for water quality, cardioquip recommended that the device receive an internal water pathway replacement or participate in cardioquip's trade in program.This would return the device to specification and full functionality.These options were relayed to the customer via email on 12/04/23.As of the date of this report the customer has not responded to these options.A follow-up will be filed if any additional information is obtained.

Event Description

Lab results (b)(6) 2023): sn (b)(6) > 1146000 mpn/ml (above acceptable limit).To remediate the device contamination, the customer either proceed with an internal water path replacement procedure or a trade-in program.

Manufacturer Narrative

It was reported to cardioquip that this device had a bacterial count outside of cardioquip specifications.Following these results, cardioquip requested the water source at the hospital also be tested.Test results for the water source exceeded the acceptable water quality limits set by cardioquip.Thus, the water source is the most likely cause for the device contamination.Following these findings, cardioquip recommended that the device receive an internal water pathway replacement to return it to specification, and that the water source be monitored according to pg.55 of the most recent mch-1000 ifu to prevent further contamination.The device has been serviced at cardioquip returning the device to specification and fully functionality.

• 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: 18381521
• MDR Text Key: 331227891
• Report Number: 3007899424-2023-00483
• 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: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• 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?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2022
• 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