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

Model Number RFP-204

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

Patient Problems Dyspnea (1816); Itching Sensation (1943); Swelling (2091)

Event Date 05/26/2020

Event Type  Injury  

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.Biocompatability has been established.

Event Description

A report was received on 27 may 2020 from the home therapy nurse (htn) of a (b)(6) year old male with multiple comorbidities including end stage renal disease, who stated the patient experienced a reaction during a home hemodialysis treatment on (b)(6) 2020.Additional information was received on 29 may 2020 from the htn indicating the patient experienced puffy eyes, itchy throat, itchy body and shortness of breath about two minutes into a home hemodialysis treatment on (b)(6) 2020.50 mg of benadryl was administered orally (time not specified) and the patient treated for a total of two hours and thirty-nine minutes.By the end of the treatment, symptoms had subsided.Per the htn the patient recovered without sequelae and continues to treat with the nxstage system one.

• 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: 10173244
• MDR Text Key: 198151977
• Report Number: 3003464075-2020-00028
• Device Sequence Number: 1
• Product Code: KPO
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K033386
• 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: 01/01/2005,06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2021
• Device Model Number: RFP-204
• Device Catalogue Number: RFP-204
• Device Lot Number: Q1908383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 132