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U.S. Department of Health and Human Services

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

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CARDIOQUIP, LLC CARDIOQUIP MODULAR COOLER-HEATER CARDIOPULMONARY BYPASS COOLER HEATER Back to Search Results
Model Number MCH-1000(M)
Device Problem Insufficient Information (3190)
Patient Problem Bacterial Infection (1735)
Event Date 02/09/2021
Event Type  Injury  
Manufacturer Narrative

(b)(6) hospital submitted a user facility report (b)(4). Cardioquip followed up with (b)(6) 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 (b)(6) 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 for respiratory failure related to covid infection. The patient was found to have positive sputum cultures 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 COOLER HEATER
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 Key11667508
MDR Text Key261203643
Report Number3007899424-2021-00008
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK102147
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 04/13/2021
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? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMCH-1000(M)
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
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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