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); Swelling/ Edema (4577)

Event Date 11/23/2020

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. The instructions for use warn that the device must be used under the prescription of a physician. 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. The patient¿s blood pressure, vital signs, general well-being, and physical status should be monitored closely throughout the treatment. Biocompatability has been established.

Event Description

A report was received on 23 nov 2020 from the nurse of a (b)(6) year old female with a medical history including diabetes, hypertension, hyperlipidemia and end stage renal disease, who stated the patient experienced an allergic reaction during their first hemodialysis treatment with the device on (b)(6) 2020. Additional information was received on 01 dec 2020 from the nurse who stated approximately thirty minutes into treatment on (b)(6) 2020 the patient experienced swelling of her eyes and face. 50mg of diphenhydramine was administered intravenously, oxygen was applied via nasal canula and the patient was transported to the emergency room. Following the event the patient recovered without sequelae and has changed to an unspecified device 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: 10985337
• MDR Text Key: 220762832
• Report Number: 3003464075-2020-00079
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• 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

• Type of Report: Initial
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 08/01/2021
• Device Model Number: CAR-170-C
• Device Catalogue Number: CAR-170-C
• Device Lot Number: 91177051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 12/10/2020 Patient Sequence Number: 1