MalfunctionDXO

TRUWAVE

Received Mar 11, 2026 · Event occurred Feb 11, 2026

Report 24567827 · MDR key 24567827

Device

Generic name

Transducer, Pressure, Catheter Tip

Manufacturer

Edwards Lifesciences Llc

Model number

PX600I

Catalog number

PX600I

Lot number

66844009

Patient

78 YR · Female

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

NURSE WAS HELPING PATIENT WITH BATH, AND NURSE HAD CHECKED THE EVD (EXTERNAL VENTRICULAR DRAIN) BEFORE EACH TURN AND IT WAS INTACT. ONCE THE BATH WAS FINISHED, NURSE WENT TO ZERO THE EVD SHE NOTICED DRIPPING AND QUICKLY REALIZED THE TRANSDUCER BECAME DISCONNECTED SPONTANEOUSLY AND CSF (CEREBROSPINAL FLUID) WAS LEAKING OUT OF IT. NURSE CHANGED OUT THE TRANSDUCER PER PROTOCOL.