MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE; HIGH PERMEABILITY HEMODIALYSIS SYSTEM

Model Number CAR-172-C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Itching Sensation (1943); Urticaria (2278)

Event Date 03/28/2023

Event Type  Injury  

Manufacturer Narrative

The cartridge was discarded and lot number not available.All devices must meet quality requirements and manufacturing specifications prior to release.There is no information to indicate that a malfunction occurred.Allergic or adverse reactions are known risks of hemodialysis.The nxstage user guide and instructions for use include allergic reaction as a potential risk associated with dialysis therapy and also include warnings to monitor for potential allergic reactions.Biocompatibility of the device has been established.

Event Description

A report was received on 07 apr 2023 from the home therapy nurse (htn) of a 70 year old male patient with a medical history including end stage renal disease, who stated the patient experienced anaphylaxis, trouble breathing, hives, generalized itchiness, and low blood pressure (90/48 mmhg) approximately fifteen minutes into an in-center hemodialysis treatment on (b)(6) 2023.Additional information was received on 11 apr 2023 from the home therapy nurse (htn) who stated the patient's symptoms improved within twenty minutes upon receiving diphenhydramine (benadryl) 25mg intravenously (iv), methylprednisolone (solu-medrol) 125mg iv, and epinephrine 1mg iv.The patient changed to a dialyzer from a different manufacturer and continues to treat with the nxstage system.

• Brand Name: NXSTAGE SYSTEM ONE
• Type of Device: HIGH PERMEABILITY HEMODIALYSIS SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack street; lawrence MA 01843
• Manufacturer (Section G): MEDIMEXICO S. DE R. L. DE C. V; av. valle imperial no. 10523; parque industrial valle sur; tijuana 22180 ; MX 22180
• Manufacturer Contact: paula rogalski ; nxstage medical, inc.; 350 merrimack street; lawrence, MA 01843 ; 9784505276
• MDR Report Key: 16768079
• MDR Text Key: 313565239
• Report Number: 3003464075-2023-00036
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/19/2023

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: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 25 KG