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

Model Number	CAR-170-C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Urticaria (2278); Swelling/ Edema (4577)
Date of Event	09/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record (dhr) was conducted which confirmed that the product met all quality criteria 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 or Problem Description
A report was received on (b)(6) 2023 from the nurse of a 40 year old male patient with a medical history including end stage renal disease, who stated the patient experienced an allergic reaction with swollen lips, itching, and a rash 30 minutes into an in-center hemodialysis treatment on (b)(6) 2023.Additional information was received on (b)(6) 2023 from the nurse who stated intravenous diphenhydramine (benadryl) 50mg and intravenous methylprednisolone (solumedrol) 125mg was administered with symptoms resolving after an hour.Following the event the patient has recovered without sequelae and will resume treatment with the nxstage system.

• Brand Name: NXSTAGE SYSTEM ONE
• Common Device Name: 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: 17754547
• Report Number: 3003464075-2023-00072
• Device Sequence Number: 6664983
• Product Code: KDI
• UDI-Device Identifier: M535CAR170C0
• UDI-Public: +M535CAR170C0/$$0524212770394
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K140526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/15/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2024
• Device Model Number: CAR-170-C
• Device Catalogue Number: CAR-170-C
• Device Lot Number: 21277039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 74 KG