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 Low Blood Pressure/ Hypotension (1914); Itching Sensation (1943); Loss of consciousness (2418)

Event Date 02/26/2018

Event Type  Injury  

Manufacturer Narrative

The device was not available for evaluation.A review of the device history record (dhr) was performed and revealed no quality issues were noted during the manufacturing of the reported lot number which was released having met all requirements and specifications.Biocompatibility of the device has been established.Allergic or adverse reactions are known risks of hemodialysis.The nxstage system one user guide includes allergic or adverse reaction as potential risks associated with dialysis treatments and the instructions for use include 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 02 mar 2018 regarding a female patient who experienced itching, hypotension, and a decreased level of consciousness approximately 20-25 minutes into a standard home hemodialysis treatment on (b)(6) 2018.Oxygen at 5 l/min and a 200 ml saline bolus were administered and the patient stabilized.The patient continues to treat without issue 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 ; 9786874700
• MDR Report Key: 7341811
• MDR Text Key: 102513836
• Report Number: 3003464075-2018-00013
• 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: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2019
• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Device Lot Number: 70977041
• Other Device ID Number: +M535CAR172C0/$$041970977041D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention