NON-DEHP MINIVOLUME EXTENSION SET
Received Jun 15, 2026 · Event occurred Apr 11, 2026
Report 25501015 · MDR key 25501015
Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PATIENT #1: [REDACTED] [REDACTED]- THE DISTAL END OF THE CARDIAC FILTER TUBING REMAINED ATTACHED TO THE PATIENT'S CVC [CENTRAL VENOUS CATHETER] RED LUMEN, WHILE THE REMAINDER OF THE TUBING HAD BROKEN OFF. I REMOVED THE BROKEN DISTAL SEGMENT, AND A CAP CHANGE WAS PERFORMED ON BOTH LUMENS. ALL TUBING AND IV FLUIDS WERE DISCARDED, AND NEW TUBING AND IV FLUIDS WERE HUNG. PATIENT #2: [REDACTED] [REDACTED] - DURING SYRINGE PUMP INFUSION OF IV LASIX, TUBING LEAKED FROM CARDIAC FILTER. DID NOT NOTICE UNTIL END OF 10-MIN INFUSION. UNCLEAR IF PATIENT RECEIVED FULL DOSE. PATIENT #3: [REDACTED] [REDACTED]- CARDIAC FILTER COMPONENT BROKEN - LEAKING BLOOD FROM CVC OUT ONTO BEDDING.