MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE CAR-170 DIALYZER CARTRIDGE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number CARTRIDGE170-C

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Swelling/ Edema (4577)

Event Date 12/22/2023

Event Type  Injury  

Event Description

Patient attended first scheduled transitional care unit dialysis treatment using a nxstage machine.Pre vital signs bp-121/81, pulse-73, resp-18, temp-97.7.At approx.1355 dialysis was initiated with a use of car-170 cartridge as prescribed.Within approx.3 minutes, patient complained of itching, treatment stopped, diphenhydramine 50 mg oral given per physician orders.Patient then complained of "bumps in her mouth", 911 called.Patient then noted to have face swelling, oxygen administered.Ems arrived and patient was administered epinephrine by ems.Patient transported to hospital via ems alert and oriented.Patient later released from the hospital.Returned to clinic and started at the in-center dialysis on (b)(6) 2023 and was treated on a f180nre dialyzer without incident.Car-170 cartridge discontinued.Car-170 cartridge marked as an allergy.

• Brand Name: NXSTAGE CAR-170 DIALYZER CARTRIDGE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.
• MDR Report Key: 18446480
• MDR Text Key: 332253877
• Report Number: MW5149777
• 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: 12/29/2023

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 Model Number: CARTRIDGE170-C
• Device Lot Number: 30677010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2024
• 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 40 LACTATE.
• Patient Outcome(s): Hospitalization
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American