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

Lot Number 30681019

Patient Problems Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Vomiting (2144); Hot Flashes/Flushes (2153); Chills (2191); Anxiety (2328); Pallor (2468)

Event Date 08/29/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, patient attended regularly scheduled home hemodialysis training using a nxstage machine.Pre vital signs bp-118/63, pulse-76, temp-97.9.Treatment started with a use of car-172 dialyzer as prescribed.Approx.20 minutes after treatment was started, patient had hypotension and nausea.Normal saline was given, patient recovered and was discharged to home stable.On (b)(6) 2023 patient attended regularly scheduled home hemodialysis training.Pre vital signs bp-108/73, pulse-88, temp(temperature) 98.4.Treatment started with a use of car-172 dialyzer as prescribed.Approx.15 minutes after treatment was started, patient became restless, pale and nauseous and normal saline was given.Patient became hypotensive, vomited, felt hot and complained of body chills.Treatment was discontinued.Patient recovered onsite and discharged to home stable with the following vital signs: bp-105/66, pulse-81.Car-172 dialyzer discontinued by physician.Car-172 dialyzer added as an allergy.Notable data: patient had a similar symptoms of hypotension and nausea previously on (b)(6) 2023.

• Brand Name: NXSTAGE CAR-172
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; lawrence MA 01843
• MDR Report Key: 17728647
• MDR Text Key: 323295381
• Report Number: MW5145530
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/06/2023

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: 30681019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEPARIN; NORMAL SALINE; NXSTAGE WITH PUREFLOW; THERAPY FLUID 2.0 K 45 LACTATE
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White