GEM FLOW COUPLER MONITOR
Received Nov 22, 2023 · Event occurred Oct 12, 2023
Report 18191389 · MDR key 18191389
Device
Generic name
Flowmeter, Blood, Cardiovascular
Manufacturer
Baxter Healthcare CorporationModel number
GEM1020M-2Catalog number
515600000011
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
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.