MAUDE Adverse Event Report: CARDIOQUIP LLP CARDIOQUIP; MODULAR COOLER HEATER UNIT (MCH)

Model Number MCH-1000

Device Problems Contamination (1120); Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Death (1802); Pneumonia (2011)

Event Date 09/09/2016

Event Type  Death  

Manufacturer Narrative

Add'l serial numbers: (b)(4).The user facility does not consider this to be a device related adverse event, reporting it as a product problem.The facility conducted an investigation and found that the hospital water system was infected with legionella, and the water in the cooler-heater devices contained legionella because it came from the contaminated hospital water supply.The investigation found no link between the cooler-heater devices and the pt infections.Cardioquip service personnel performed onsite eval of all cooler-heater devices (the three listed on this form, and nine others) and found no evidence of malfunction or misuse.Hospital personnel performed the cleaning and disinfection procedure, per the device ifu, and removed the contaminants from the three devices that had been contaminated with legionella from the hospital water supply.Cardioquip service personnel verified that the hospital personnel performed the cleaning and disinfection procedures adequately.

Event Description

Two pts who had surgery, later tested positive for legionnaires' pneumonia.During hospital's investigation into potential source, 3 operating room cooler-heater units tested positive for legionella bacteria.There has been no conclusive evidence at this time to link the pneumonia to the equipment.Ref (b)(4).

• Brand Name: CARDIOQUIP
• Type of Device: MODULAR COOLER HEATER UNIT (MCH)
• Manufacturer (Section D): CARDIOQUIP LLP; 3827 old college rd; bryan TX 77801 0000
• Manufacturer Contact: 3827 old college rd; bryan, TX 77801 ; 9196910202
• MDR Report Key: 6116548
• MDR Text Key: 60652714
• Report Number: 3007899424-2016-00001
• 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: user facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MCH-1000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2016
• Distributor Facility Aware Date: 09/05/2016
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2016
• Date Manufacturer Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 56 YR