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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOQUIP, LLC CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE

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CARDIOQUIP, LLC CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE Back to Search Results
Model Number MCH-1000 (M)
Device Problems Microbial Contamination of Device (2303); Insufficient Information (3190)
Patient Problem Bacterial Infection (1735)
Event Date 11/05/2020
Event Type  Injury  
Manufacturer Narrative
(b)(6) submitted a user facility report (b)(4). Cardioquip followed up with bwh to request the device be returned to cardioquip for investigation. (b)(6) did allow cardioquip's personnel to come onsite but personnel were not given access to the device. Additionally, at the time of this report, the device has not been returned to cardioquip for investigation and any results from testing performed on the device by (b)(6) have not been supplied to cardioquip. Cardioquip is in continuous dialogue with bwh regarding their investigation and potential for the device to be returned to cardioquip at a later date.
 
Event Description
Describe the event or problem: 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. The associated user facility report is mdr (b)(4).
 
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Brand NameCARDIOQUIP MODULAR COOLER HEATER
Type of DeviceCARDIOPULMONARY BYPASS DEVICE
Manufacturer (Section D)
CARDIOQUIP, LLC
8422 calibration ct.
college station TX 77845
Manufacturer (Section G)
CARDIOQUIP, LLC
8422 calibration ct.
college station TX 77845
Manufacturer Contact
charley ford
8422 calibration ct.
college station, TX 77845
9796910202
MDR Report Key11667536
MDR Text Key245513468
Report Number3007899424-2021-00005
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMCH-1000 (M)
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/05/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/14/2021 Patient Sequence Number: 1
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