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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOQUIP MCH-1000; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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CARDIOQUIP MCH-1000; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number MCH-1000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 06/10/2020
Event Type  malfunction  
Event Description
Three patients developed sternal surgical site infections post cardiac surgery with m.Abscessus.Following performance of environmental cultures of the water sources in and around the operating room, the only growth of m.Abscessus we have identified is within the reservoir and tubing of four cardioquip heater/coolers, leading us to believe that the heater cooler contributed to the surgical site infections.Manufacturer response for heater cooler, mch-1000 (per site reporter).Manufacturer said they would review cleaning protocols and will come in to do a refresher on cleaning and disinfecting of the heater coolers.
 
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Brand Name
MCH-1000
Type of Device
CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
CARDIOQUIP
3827 old college rd
bryan TX 77801
MDR Report Key10205756
MDR Text Key196775778
Report Number10205756
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/18/2020,06/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberMCH-1000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/18/2020
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer06/29/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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