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

Model Number	GEM2752 FC
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ring of a 2.0mm flowcoupler was not aligned, which prevented the use of the device during surgery.This was observed during an intra-op procedure.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
E1: initial reporter phone no.: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: d4, d9, h3, h4, h6 (update codes), h11.H11: the actual device was received for evaluation.Visual inspection identified the flow coupler ring improperly seated in the jaw assembly; the flow coupler ring was seated in an upside-down orientation most likely by the user prior to returning the product for evaluation.If the ring had been placed in the jaw assembly in the orientation in which the device was returned, the insertion of the probe would not have been able to take place per standard manufacturing procedure and the jaw assembly would have been scrapped.Due to the device orientation by the user, the reported condition could not be verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave w.; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22731153
• Report Number: 1416980-2025-04062
• Device Sequence Number: 21080207
• Product Code: DPW
• UDI-Device Identifier: 00844735005998
• UDI-Public: (01)00844735005998(10)SP23K07-1970241(17)281105
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: GEM2752 FC
• Device Catalogue Number: 515101200010
• Device Lot Number: SP23K07-1970241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2023
• 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