inforMED
MalfunctionFOX

EKOS¿ CU 4-0 CART

Received Jun 18, 2024 · Event occurred Mar 8, 2024

Report 19556920 · MDR key 19556920

Device

Generic name

Stand, Infusion

Model number

700-60401

Catalog 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.