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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOQUIP, LLC MCH-1000 CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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CARDIOQUIP, LLC MCH-1000 CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 11/05/2020
Event Type  Injury  
Event Description
Additional details for this patient: the patient was initially cannulated for ecmo after lung transplant. The patient was found to have positive blood and sputum cultures respectively for burkholderia. The patient was able to come off ecmo. The patient continues to be treated. Manufacturer response for heater/cooler, (b)(4) (per site reporter): no response to date.
 
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Brand NameMCH-1000
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
CARDIOQUIP, LLC
8422 calibration ct
college station TX 77845
MDR Report Key11452954
MDR Text Key238877270
Report Number11452954
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,Followup
Report Date 03/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/09/2021
Event Location Hospital
Date Report to Manufacturer03/10/2021
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

Patient Treatment Data
Date Received: 03/10/2021 Patient Sequence Number: 1
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