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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOQUIP MODULAR COOLER-HEATER (MCH) CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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CARDIOQUIP MODULAR COOLER-HEATER (MCH) CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number MCH-1000
Device Problem Contamination (1120)
Patient Problem Unspecified Infection (1930)
Event Date 11/25/2020
Event Type  Malfunction  
Event Description

In (b)(6) 2020, our facility was notified by the fda that patients from one organization had experienced ntm infections (m abscessus) after heart surgery where the cardioquip heater cooler devices were used. This prompted our organization to send samples from our machines to an outside lab for testing. 5/8 cardioquip devices came back positive for ntm. Lab results available. We have not identified any related infections at this time. Upon receiving these results, a group convened and learned the following: testing of our 8 devices revealed 5 of 8 machines contaminated with ntm, no known infections with ecmo patients and use of cardioquip in the literature, risk for infection is very low, but not zero. We only use the device to heat-not to cool. Standard work for machine use and cleaning very rigorous, however design of machine is flawed. Next steps include: continued use of the three machines that tested negative, since there is no acceptable substitute. All three will be re-tested, report to fda, connect with the manufacturer, potential retrospective review of 200 ecmo patients.

 
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Brand NameMODULAR COOLER-HEATER (MCH)
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
CARDIOQUIP
8422 calibration ct
college station TX 77845
MDR Report Key10940079
MDR Text Key219328325
Report Number10940079
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 RISK MANAGER
Type of Report Initial
Report Date 11/30/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/03/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberMCH-1000
Device LOT Number537766
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/30/2020
Event Location Hospital
Date Report TO Manufacturer12/03/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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