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

Model Number CAR-170-C

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

Patient Problems Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Reaction (2414); Loss of consciousness (2418); Chest Tightness/Pressure (2463)

Event Date 11/13/2018

Event Type  Injury  

Manufacturer Narrative

A review of the device history record (dhr) for the involved lot was conducted which revealed 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's 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.

Event Description

A report was received on (b)(6) 2018 from the home therapy nurse (htn) regarding gg, a (b)(6) year old male with multiple comorbidities and medical history significant for recent dyspnoea, chest discomfort (nos), and intradialytic hypotension with loss of consciousness four (4) days prior, who became symptomatic 6 mins after commencing a standard hemodialysis treatment in a dialysis facility on (b)(6) 2018.Symptoms included shortness of breath, chest discomfort, hypotension and loss of consciousness.Rinseback was performed to return blood in the extracorporeal circuit and emergency services were called.Patient symptoms improved with use of supplemental oxygen and the patient was hospitalized.Hemodialysis using a system from a different manufacturer was performed in hospital and the patient was discharged on (b)(6) 2018 to continue hemodialysis treatments with the alternate device.Per the physician the patient had an atypical reaction to the dialyzer.

• 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: 8116208
• MDR Text Key: 128874629
• Report Number: 3003464075-2018-00065
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: M535CAR170C0
• UDI-Public: +M535CAR170C0/$$071971277029E
• 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: 01/01/2005,11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2019
• Device Model Number: CAR-170-C
• Device Catalogue Number: CAR-170-C
• Device Lot Number: 71277029
• 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: 11/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 36 YR
• Patient Weight: 103