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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 Problems Bacterial Infection (1735); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/20/2021
Event Type  malfunction  
Manufacturer Narrative
In follow-up communication with the (b)(6) personnel, the (b)(6) personnel indicated they are utilizing genetic mapping to try and determine whether the pseudomonas aeruginosa found within the cardioquip device is the same, genetically, as what was found in the patients. (b)(6) also reported that multiple sites at the facility tested positive for pseudomonas aeruginosa including sink drains, icu sinks, patient hot water blankets, and slush machines. (b)(6) testing found that the pseudamonas aeruginosa found in the patient did not match the tested isolates from the or including the cardioquip device indicating no direct link between the adverse event and the cardioquip device. Cardioquip continues to work with (b)(6) to further the investigation of this event and assist in determining the source of the patient infections. At this time cardioqup has not received the data from the testing performed by (b)(6). If cardioquip is able to obtain the testing results from (b)(6) or if more relevant information regarding this adverse event is identified a follow-up report will be filed.
 
Event Description
The customer, perfusion manager, reported via conference call with distributor and cardioquip that he was made aware of 3 pseudomonas aeruginosa patient infections and that cardioquip devices in the or had positive cultures of pseudamonas aeruginsoa. He is unaware of the timeframe of the patient infections or the patients' infection site or condition.
 
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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 Key12321691
MDR Text Key267282603
Report Number3007899424-2021-00013
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 Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2021
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 Received07/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/26/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 08/13/2021 Patient Sequence Number: 1
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