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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 Problem Microbial Contamination of Device (2303)
Patient Problem Bacterial Infection (1735)
Event Date 01/18/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6) hospital submitted a user facility report (b)(4). Cardioquip followed up with bwh to request the device be returned to cardioquip for investigation. (b)(6) requested the device be held for investigation by bwh's personnel and have cardioquip assist in disassembling the device. (b)(6) allowed cardioquip's personnel to come onsite and view the device. Cardioquip was not permitted to perform any form of verification or testing of the device to confirm involvement in the report. (b)(6) indicated they would perform testing of the device to determine contamination and the results of the testing would be supplied to cardioquip. (b)(6) provided a description of the results but did not provide the quantitative data that would allow for further investigation and evaluation of the event. Cardioquip continues to maintain dialogue with bwh regarding this event.
 
Event Description
Describe the event or problem: additional details for this patient: the patient was initially cannulated for ecmo after coronary valve replacement surgery. The patient was found to have positive blood and 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 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 Key11659597
MDR Text Key247073739
Report Number3007899424-2021-00003
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
Remedial Action Inspection
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 Received04/13/2021
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? Yes
Date Device Manufactured05/01/2020
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: 04/13/2021 Patient Sequence Number: 1
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