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

Model Number CAR-172-C

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Apnea (1720); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418); Sweating (2444)

Event Date 02/05/2021

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.No device malfunction is associated with this report.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.Biocompatibility has been established.

Event Description

A report was received on 05 feb 2021 from the nurse of a male patient, with a medical history including iga nephropathy, hypertension, gout and end stage renal disease, who stated the patient became unresponsive and diaphoretic approximately twenty minutes into his first hemodialysis treatment with the nxstage system on (b)(6) 2021.Symptoms resolved with return of the blood circuit via rinseback.Shortly after symptoms resolved (time not specified), the patient was rechallenged and within one minute became unresponsive with low blood pressure (104/62mmhg), diaphoresis and a decreased respiratory rate (nos).Emergency medical services (ems) were called and rinseback of the blood circuit was performed.Symptoms resolved prior to ems arrival and no medical intervention was required.Additional information was received on 10 feb 2021 from the nurse stating no dyspnea or apnea was associated with the decreased respiratory rate.The patient recovered without medical intervention and his physician prescribed a dialyzer from a different manufacturer for his ongoing hemodialysis treatments.

Manufacturer Narrative

The purpose of the supplemental report is to clarify that the mdr submitted is not the subject of an approved exemption and therefore number ¿5645646¿ included in the ¿exemption number¿ field was submitted in error.

• Brand Name: NXSTAGE SYSTEM ONE
• Type of Device: HIGH PERMEABILITY HEMODIALYSIS SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack street; lawrence MA 01843
• MDR Report Key: 11408107
• MDR Text Key: 234893735
• Report Number: 3003464075-2021-00008
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: M535CAR172C0
• UDI-Public: +M535CAR172C0/$$0522009770220
• Combination Product (y/n): Y
• PMA/PMN Number: K140526
• Exemption Number: 5645646
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2022
• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Device Lot Number: 00977022
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other