MAUDE Adverse Event Report: CARDIOQUIP CARDIOQUIP CARDIOPULMONARY BYPASS TEMP CONTROLLER; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number MCH-1000

Patient Problem Insufficient Information (4580)

Event Date 03/26/2024

Event Type  malfunction  

Event Description

This is voluntary notice.No patient harm.On 3/26/2024 carioquip reported the following regarding findings during preventive maintenance of three cardiopulmonary bypass temperature controllers: upon inspection of internal components, our technician has identified potential contamination with the following units: sn (serial numbers) (b)(6), and (b)(6) (chemical).Our director of epidemiology has reviewed the images and reports taken by our field service technician.Based on what we can see, cardioquip recommends performing a quarterly cleaning & disinfection according to the ifu(instructions for use).Potential contamination in your device may be reduced or eliminated by performing cleaning and disinfection procedures located on pg.55 ¿ 59 of the mch-1000 operator/service manual.Cardioquip recommends using minncare¿ cold sterilant.After the cleaning and disinfection is complete, cardioquip also recommends performing heterotrophic plate count (hpc) testing on the impacted unit(s) to provide a quantitative assessment of water quality.Cardioquip provides hpc test kits to facilities for (b)(6) per kit, and includes detailed instructions, all collection items required to obtain a sample, and testing.An hpc test kit quote is attached.The kit(s) will be shipped to you when we receive a hard copy of the po.Once the water samples are submitted via mail, test results generally arrive in 4-5 business days.If test results come back with an acceptable reading, no action is required and units may be returned to service.If test results come back with a reading greater than 100 cfu/ml, there are several options for remediation including internal water path replacement (iwpr) or cardioquip's trade-in program.A software update was performed for all mch-1000 units, updating units to version 020216.Was this device serviced by a third party servicer? yes.Reference reports: mw5153826, mw5153828.

• Brand Name: CARDIOQUIP CARDIOPULMONARY BYPASS TEMP CONTROLLER
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIOQUIP; college station TX 77845
• MDR Report Key: 19104628
• MDR Text Key: 340369985
• Report Number: MW5153827
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/10/2024

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 Operator: Health Professional
• Device Model Number: MCH-1000
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1