MalfunctionFKR

NXSTAGE PUREFLOW PAK

Received Jun 17, 2026 · Event occurred Jun 10, 2026

Report MW5189522 · MDR key 25531997

Device

Generic name

Subsystem, Proportioning

Manufacturer

Nxstage Medical, Inc.

Lot number

60274036

Patient

63 YR · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

(B)(6) / 63 YEAR OLD DIALYSIS PATIENT USING NXSTAGE SYSTEM ONE WITH PUREFLOW FOR AT HOME HEMODIALYSIS. PUREFLOW FILTER PAK EXHAUSTED AFTER 1 TREATMENT. THIS HAS BEEN AN ONGOING ISSUE SINCE (B)(6) 2025.