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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOQUIP LLC CARDIOQUIP HEATER COOLER DEVICE; HEATER-COOLER
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CARDIOQUIP LLC CARDIOQUIP HEATER COOLER DEVICE; HEATER-COOLER Back to Search Results
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Based on the guidance received from the fda letter to healthcare provider originally dated september 30, 2020 and further updated, we are submitting a voluntary report.On january 16, 2024 during routine quarterly inspection, (b)(6) medical center clinical engineering staff identified discolored tubing and visible bioburden on one cardioquip machine.The machine with visible bioburden was pulled from service on january 16, 2024.The manufacturer was notified on january 17, 2024 and provided heterotrophic plate count (hpc) test kits.Samples were collected on the machine with visible issues as well as two other machines (total of three machines) on 2/5/2024.Results of testing were received 2/9/2024 and were higher than normal limits on all three machines and the other two machines were pulled from service that day.We immediately initiated an internal investigation to understand if we had any process concerns.Our infection preventionists traced the process for handling and maintaining the equipment using the manufacturer's instructions for use (mifus).To date, no material gaps have been identified in following weekly and quarterly inspections relative to the cardioquip mifus.Reference report # mw5152325, mw5152327.
 
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Brand Name
CARDIOQUIP HEATER COOLER DEVICE
Type of Device
HEATER-COOLER
Manufacturer (Section D)
CARDIOQUIP LLC
MDR Report Key18845238
MDR Text Key337122926
Report NumberMW5152326
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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