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

Model Number CAR-170-C

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Cough (4457); Wheezing (4463)

Event Date 09/22/2023

Event Type  Injury  

Manufacturer Narrative

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 (b)(6) 2023 from the home therapy nurse (htn) of a 65 year old male patient with a medical history including end stage renal disease, who stated the patient experienced a cough, wheezing and was itchy during a home hemodialysis treatment on (b)(6) 2023.Per the htn, the patient improved upon using his nebulizer and ending the treatment.Additional information was received on (b)(6) 2023 from the htn, who stated the patient was administered 25mg of oral diphenhydramine (benadryl) and recovered without sequelae, no report of additional symptoms.Per the htn, the patient plans to resume therapy with the nxstage system using a dialyzer from a different manufacturer.

• 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: 17884763
• MDR Text Key: 325066521
• Report Number: 3003464075-2023-00085
• 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: 10/06/2023

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: Lay User/Patient
• Device Model Number: CAR-170-C
• Device Catalogue Number: CAR-170-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2023
• 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): Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 88 KG