FDA Adverse Event Injury Summary report: N

HHD CARTRIDGE

MDR report key: 22804785 · Received August 14, 2025

Report

Report Number: MW5174527
Event Type: Injury
Date Received: August 14, 2025
Date of Event: August 9, 2025
Report Date: August 11, 2025
Manufacturer: NXSTAGE MEDICAL, INC.
Product Code: KDI
Adverse Event: Yes
Product Problem: Yes
Report Source: Voluntary report
Reporter Location: NJ, US
Reporter Occupation: PATIENT
Health Professional: *

Narratives

Description of Event or Problem · 0

I AM ON HOME HEMODIALYSIS AND USE NXSTAGE CARTRIDGES. ON (B)(6) 2025 I OPENED A NEW BOX, REF # CAR-170-E LOT # 50477088. THE FIRST INDIVIDUAL CARTRIDGE I OPENED I NOTED A LOOSE CAP FALL OUT AS I REMOVED IT FROM THE SLEEVE. I INSPECTED THE CARTRIDGE AND COULD NOT IDENTIFY ANY LINES MISSING A CAP, BUT STILL DISCARDED THAT CARTRIDGE. THE SECOND CARTRIDGE I OPENED FROM THE SAME BOX SEEMED INTACT. I SET UP THE MACHINE SUCCESSFULLY AND INITIATED TREATMENT. LESS THAN TEN MINUTES INTO TREATMENT, THE FLUID DETECTOR ALARM STARTED GOING OFF AND A LOW EFFLUENT PRESSURE ALARM STARTED ON THE MACHINE. I COULD SEE A LARGE PUDDLE BENEATH THE MACHINE AND DRIPPING FROM INSIDE WHERE THE CARTRIDGE IS HELD. I HAD TO TERMINATE TREATMENT WITHOUT RETURNING MY BLOOD, CAUSING A BLOOD LOSS. AFTERWARD WHEN I WAS TEARING DOWN THE MACHINE AND REMOVED THE CARTRIDGE, I NOTED THE POUCH AREA ON THE REAR SIDE OF THE CARTRIDGE, WHEN ANY PRESSURE WAS APPLIED, SPRAYING A TINY STREAM FROM A HOLE THAT WAS NOT VISIBLE TO THE NAKED EYE. BOTH CARTRIDGES THAT I OPENED FROM THE SAME BOX EACH HAD AN ISSUE. PATIENT:4582. DEVICE:2907,1250,1504. REFERENCE REPORT: MW5174528.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1226232	HHD CARTRIDGE	DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	KDI	NXSTAGE MEDICAL, INC.	CAR-170-E	50477088

Patients

Seq	Age	Sex	Outcome	Treatment
1	37 YR	Male	Other