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 Hypersensitivity/Allergic reaction (1907); Nausea (1970); Vomiting (2144)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

The device was not retained for investigation.A lot number was not identified.All available information supports that the product was functioning as designed and there was no malfunction.Biocompatibility of the device has been established.The nxstage user guide includes hypersensitivity and platelet decrease as potential risks associated with dialysis treatments.

Event Description

A report was received on (b)(6) 2017 of a (b)(6) male patient with unknown comorbidities who experienced a hypersensitivity reaction with symptoms of persistent coughing, nausea and vomiting during a standard home hemodialysis treatment on (b)(6) 2017.The patient was switched to a dialyzer from a different manufacturer on (b)(6) 2017.No medical intervention was reported.

• 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: 7135735
• MDR Text Key: 95453796
• Report Number: 3003464075-2017-00056
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K140526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 57 YR
• Patient Weight: 63