GEM FLOW COUPLER
Received Nov 13, 2024 · Event occurred Oct 14, 2024
Report 1416980-2024-06523 · MDR key 20679433
Device
Generic name
Flowmeter, Blood, Cardiovascular
Manufacturer
Baxter Healthcare CorporationModel number
GEM2753 FCCatalog number
515101250010
Lot number
SP24G24-2111551
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A RING OF A 2.5MM FLOW COUPLER FELL OUT. THIS WAS OBSERVED DURING VENOUS ANASTOMOSIS, AFTER A VEIN WAS INSTALLED INTO ONE SIDE OF THE COUPLER; THE OTHER SIDE OF THE COUPLER FELL OFF THE APPLICATOR. THERE WAS NO REPORT OF PATIENT INJURY; HOWEVER, A NEW COUPLER WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D4, H4, H6, H11. 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.