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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION GEM FLOW COUPLER MONITOR; FLOWMETER, BLOOD, CARDIOVASCULAR
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BAXTER HEALTHCARE CORPORATION GEM FLOW COUPLER MONITOR; FLOWMETER, BLOOD, CARDIOVASCULAR Back to Search Results
Model Number GEM1020M-2
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2023
Event Type  malfunction  
Event Description
The device is a flow coupler monitor.The probe is what comes in contact with the patient.The probe plugs into the flow coupler monitor.The surgeon uses the probe to hear blood flow through a coupler device they just surgically implanted in the patient.The circulating nurse in the room turns on the monitor and plugs the probe into it, while the surgeon uses the other end of the probe on the sterile field to listen for the blood flow.The monitor did not produce adequate sound when attempted to be used.It was switched out with a different brand monitor and that worked.
 
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Brand Name
GEM FLOW COUPLER MONITOR
Type of Device
FLOWMETER, BLOOD, CARDIOVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
one baxter parkway
deerfield IL 60015
MDR Report Key18191389
MDR Text Key328797100
Report Number18191389
Device Sequence Number1
Product Code DPW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberGEM1020M-2
Device Catalogue Number515600000011
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/15/2023
Event Location Hospital
Date Report to Manufacturer11/22/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/22/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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