EKOS¿ CU 4-0 CART
Received Jun 18, 2024 · Event occurred Mar 8, 2024
Report 19556920 · MDR key 19556920
Device
Generic name
Stand, Infusion
Manufacturer
Boston Scientific CorporationModel number
700-60401Catalog number
700-60401
Lot number
MW072321
Patient
2 MO · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
EKOS ENDOVASCULAR SYSTEM DISPLAYED "CONNECTION ERROR" MESSAGE FOR LINE RUNNING TO B PORT/ SHEATH (RIGHT IJ SHEATH). ALL VISIBLE CONNECTIONS WERE CHECKED, BUT THE DEVICE CONTINUED TO DISPLAY THE SAME ERROR MESSAGE (ERROR: E311). CARDIAC FELLOW WAS NOTIFIED AND AT BEDSIDE, UNABLE TO RESOLVE THE PROBLEM. REGISTERED NURSE (RN) CALLED EKOS/ BOSTON SCIENTIFIC HELPLINE BUT WAS UNABLE TO REACH A TECHNICIAN. THE DEVICE WAS SHUT OFF AFTER OVER AN HOUR OF TROUBLE SHOOTING BY RN AND FELLOW. TPA AND HEPARIN INFUSION FOR BOTH IJ SHEATHS HAD ALREADY BEEN COMPLETED AND WERE THEREFORE NOT IMPACTED BY THE MALFUNCTION.