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

Model Number CAR-170-C

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Urticaria (2278); Anxiety (2328)

Event Date 04/02/2019

Event Type  Injury  

Manufacturer Narrative

A review of the device history record (dhr) for the involved cartridge lot was conducted which confirmed the product met all quality criteria and manufacturing specifications prior to release.Biocompatibility of the device has been established.There is no evidence to suggest that a product malfunction occurred.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 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 03 apr 2019 from the home therapy nurse (htn) regarding a (b)(6) male with a history of a recent hypersensitivity type reaction during hemodialysis, who experienced anxiety, hypotension and hives at an unspecified time during a standard hemodialysis treatment on (b)(6) 2019.Treatment was terminated with rinseback and 25mg of intravenous (iv) benadryl was administered.

• 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: 8533116
• MDR Text Key: 142543309
• Report Number: 3003464075-2019-00012
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: M535CAR170C0
• UDI-Public: +M535CAR170C0/$$1120902770270
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/01/2005,04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Model Number: CAR-170-C
• Device Catalogue Number: CAR-170-C
• Device Lot Number: 90277027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 89