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

Model Number MCH-1000

Patient Problems Death (1802); Pneumonia (2011)

Event Date 09/09/2016

Event Type  Death  

Event Description

Two pts who had surgery, later tested positive for legionaries 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.

• Brand Name: CARDIOQUIP
• Type of Device: MODULAR COOLER HEATER UNIT (MCH)
• Manufacturer (Section D): CARDIOQUIP; 3827 old college rd; bryan TX 77801
• MDR Report Key: 5994706
• MDR Text Key: 56540008
• Report Number: 5994706
• Device Sequence Number: 3
• Product Code: DWC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2016
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 56 YR