TRUWAVE
Received Apr 22, 2026 · Event occurred Mar 31, 2026
Report 2015691-2026-14581 · MDR key 24949062
Device
Generic name
Transducer, Pressure, Catheter Tip
Manufacturer
Edwards Lifesciences DrModel number
PX284Lot number
67122581
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING USE THE TRUWAVE PRESSURE MONITORING SET HAD BLOOD/SALINE FREE FLOWING THROUGH TRANSDUCER. THE PATIENT RECEIVED NS BOLUS VIA ARTERIAL LINE. IT IS UNKNOWN IF PATIENT HARM OCCURRED.
Additional Manufacturer Narrative
THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW. G4. ADDITIONAL PMA/510K: K171996, K183413.