MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE CAR-172 DIALYZER CARTRIDGE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Lot Number 30477024

Patient Problems Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Sore Throat (2396); Unspecified Ear or Labyrinth Problem (4474)

Event Date 10/23/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, patient attended first scheduled home hemodialysis training using a nxstage machine.Pre vital signs bp-170/93, pulse-66, temp-97.1.Dialysis treatment was initiated with a use of car-172 dialyzer as prescribed.Approx 30 minutes after treatment was initiated, the patient complained of "my ears feel like they need to pop, and throat is starting to feel sore".Treatment ended, physician notified, benadryl 25 mg po given, normal saline and oxygen administered.Patient became hypertensive, clonidine 0.1 mg po given.Ems transported patient to hospital alert and oriented, and later released.Car-172 dialyzer discontinued by physician.Car-172 dialyzer added as an allergy.

• Brand Name: NXSTAGE CAR-172 DIALYZER CARTRIDGE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; lawrence MA 01843
• MDR Report Key: 18074335
• MDR Text Key: 327532030
• Report Number: MW5147776
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 30477024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NORMAL SALINE; NXSTAGE WITH PUREFLOW; THERAPY FLUID 1.0 K 45 LACTATE
• Patient Outcome(s): Hospitalization
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 47 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White