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U.S. Department of Health and Human Services

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

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CARDIOQUIP, LLC CARDIOQUIP MODULAR COOLER-HEATER CARDIOPLUMONARY BYPASS COOLER HEATER Back to Search Results
Device Problem Microbial Contamination of Device (2303)
Patient Problem Bacterial Infection (1735)
Event Date 05/10/2021
Event Type  Injury  
Manufacturer Narrative

Mw5102484 received in the mail on july 27, 2021 stating the following: microbial contamination of heater cooler device water reservoirs potentially contributing to cardiac surgical site infections. Eleven patients developed pseudomonas aeruginosa sternal surgical site infection (ssi) a median of 24 days (range, 11-54 days) after undergoing median sternotomy incision with use of cardiopulmonary bypass with the cardioquip heater cooler device for valve replacement (n=7) or cabg (n=4) cardiac surgical procedures. Five different cardioquip mch-1000(i) devices were utilized for these 11 cardiac surgeries. The water reservoir of one of the heater cooler devices used for 4 of the 11 procedures and one additional heater cooler device not used for any of the 11 procedures both grew p. Aeruginosa. The heater cooler devices had been maintained and cleaned according to the manufacturer's instructions for use. Both the ice machines and the potable water used to fill and clean the water reservoirs used 0. 2 micron microbiologic filters. Nine available patient and 3 environmental p. Aeruginosa isolates were sent out for whole genome sequencing (wgs) analysis to assess strain relatedness. Wgs analysis demonstrated that 8 of 9 patient isolates were the same strain type, whereas none of 3 environmental isolates were related to any of the patient isolates or each other. Therefore, the microbial contamination of the heater cooler devices is not directly linked to the outbreak of cardiac ssi. Following modification of the procedures for intraoperative use and cleaning of the cardioquip devices, no additional cases of p. Aeruginosa ssi have been identified among patients undergoing cardiac surgery procedures. Therapy dates: (b)(6) 2021. Fda safety report id# (b)(4). Follow-up with the customer identified a total of 11 patients were involved with this medwatch report. A separate report is being filed for each patient, however customer was unable to provide 2 serial numbers. Cardioquip's review, based on the information described in the user facility medwatch report (mw5102484), the information describes that the patient isolates and environmental isolates are not related thus indicating that the heater-cooler used during the patient's surgery is not directly linked to the patient's infection. This is supported by the whole genome sequencing (wgs) that (b)(6) (medical director of healthcare epidemiology) reported was conducted in the user facility medwatch report.

 
Event Description

On (b)(6) 2021 s/p cabg x 1, avr, zone 1 aortic arch repair. Developed sternal surgical site infection (deep incisional) with p. Aeruginosa (b)(6) 2021. Required sternal debridement, pectoralis flaps (b)(6) 2021; wire removal, flap revision (b)(6) 2021 and antibiotics.

 
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Brand NameCARDIOQUIP MODULAR COOLER-HEATER
Type of DeviceCARDIOPLUMONARY 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 Key12381018
MDR Text Key273606601
Report Number3007899424-2021-00023
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 HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 08/27/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/27/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2021
Was Device Evaluated By Manufacturer? No
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: 08/27/2021 Patient Sequence Number: 1
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