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

Model Number CAR-172-C

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Vomiting (2144); Reaction (2414); Alteration In Body Temperature (2682)

Event Date 11/02/2017

Event Type  Injury  

Manufacturer Narrative

The cartridge was not retained for investigation.The device history record was reviewed and no related defects were found during the manufacturing of this lot.Biocompatibility of the device has been established.Allergic or adverse reactions are known risks of hemodialysis.The nxstage one user guide includes allergic or adverse reaction as potential risks associated with dialysis treatments and also includes warnings to observe the patient and monitor physical status for potential complications.Nxstage medical considers this report closed.No additional information will be provided.

Event Description

A report was received on (b)(6) 2017 from a home therapy nurse regarding a (b)(6) -year-old female patient who became symptomatic approximately one hour into a standard in center hemodialysis treatment on (b)(6) 2017.The patient developed symptoms of hypotension, vomiting and feeling cold.A saline bolus was administered and the symptoms resolved with no additional medical intervention.

• 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 ; 9786874700
• MDR Report Key: 7048498
• MDR Text Key: 92631620
• Report Number: 3003464075-2017-00050
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2019
• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Device Lot Number: 70877007
• Other Device ID Number: +M535CAR172C0/$$021970877007C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR