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U.S. Department of Health and Human Services

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

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CARDIOQUIP LLP CARDIOQUIP MODULAR COOLER HEATER UNIT (MCH) Back to Search Results
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).
 
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Brand NameCARDIOQUIP
Type of DeviceMODULAR 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 Key6116548
MDR Text Key60652714
Report Number3007899424-2016-00001
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102147
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
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 Received10/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMCH-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 FDA09/21/2016
Distributor Facility Aware Date09/05/2016
Device Age13 MO
Event Location Hospital
Date Report to Manufacturer09/21/2016
Date Manufacturer Received09/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/27/2016 Patient Sequence Number: 1
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