GEM FLOW COUPLER
Received May 28, 2026 · Event occurred Apr 27, 2026
Report 1416980-2026-01791 · MDR key 25316825
Device
Generic name
Device,anastomotic,microvascular
Manufacturer
Baxter Healthcare CorporationModel number
515101300010Catalog number
515101300010
Lot number
SP26A09-2396465
Product problems
- Failure to Sense
Patient
NA · Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE CABLE PART OF A FLOWCOUPLER SYSTEM TO SKIN STOPPED WORKING (NO SIGNAL). TO RESOLVE THIS ISSUE, THE INCISION WAS REOPENED AND THE SURGEON CHECKED FOR VESSEL PATENCY USING AN EXTERNAL DOPPLER DIRECTLY ON THE WALL. NO ISSUES WERE DISCOVERED WITH PATENCY, AND ANOTHER COUPLER UNIT WAS OPENED TO REPLACE THE EXISTING WIRE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.