MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION GEM FLOW COUPLER; FLOWMETER, BLOOD, CARDIOVASCULAR

Model Number	GEM2754 FC
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the rings of a 3.0mm flow coupler were misaligned during a venous anastomosis procedure on a patient.The rings did close; however, the "prongs did not match up properly from one side of the jaw assembly to the other reciprocal side receiver".There was no report of patient injury; however, the device was explanted and replaced to redo the anastomosis.No additional information is available.
Additional Manufacturer Narrative
Additional information: h11: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: GEM FLOW COUPLER
• Common Device Name: FLOWMETER, BLOOD, CARDIOVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - SAINT PAUL - MCA; 2575 university ave w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 21377324
• Report Number: 1416980-2025-00611
• Device Sequence Number: 19789981
• Product Code: DPW
• UDI-Device Identifier: 00844735006018
• UDI-Public: (01)00844735006018(10)SP24J08-2152645(17)291007
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K132727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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
• Operator of Device: Health Professional
• Device Model Number: GEM2754 FC
• Device Catalogue Number: 515101300010
• Device Lot Number: SP24J08-2152645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2024
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown