MalfunctionDXO
TRUWAVE PRESSURE MONITORING SET
Received Nov 12, 2025 · Event occurred Oct 31, 2025
Report MW5178821 · MDR key 23544292
Device
Generic name
Transducer, Pressure, Catheter Tip
Manufacturer
Edwards Lifesciences Llc.Catalog number
PX284
Lot number
66321914
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING SET UP FOR ARTERIAL LINE PLACEMENT A LEAK WAS DISCOVERED DURING INSPECTION OF THE DEVICE. THE PRESSURE MONITORING SET WAS LEAKING AROUND THE FLUID CHAMBER. DISCOVERED PRIOR TO USE- NO PATIENT HARM. EDWARDS TRUWAVE, 3CC/84 INCH, REF PX284, 66321914.