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

Model Number NX1000-3

Device Problem Insufficient Information (3190)

Patient Problems Congestive Heart Failure (1783); Dyspnea (1816); Edema (1820); Patient Problem/Medical Problem (2688)

Event Date 08/10/2018

Event Type  Injury  

Manufacturer Narrative

The device was not received for evaluation and no log files were available for analysis.A review of the device history record (dhr) for the cycler was conducted and revealed the product was released having met all design and manufacturing specifications and requirements.(b)(4).

Event Description

A report was received on 13 aug 2018 from the caregiver of a (b)(6) male with medical history significant for multiple cardiac and pulmonary comorbidities [chronic congestive heart failure (chf), coronary artery disease (cad), atrial fibrillation (af), chronic obstructive pulmonary disease (copd), hypertension and an aortic valve replacement (avr)], stating that the patient was hospitalized with fluid overload, peripheral edema and dyspnoea on (b)(6) 2018.Information received from the patient¿s home therapy nurse (htn) revealed that the patient was admitted on (b)(6) 2018 and discharged on (b)(6) 2018 with a diagnosis of acute on chronic systolic congestive heart failure.The patient received dialysis treatments in hospital for removal of fluid and was discharged with instruction to continue home hemodialysis treatments with nxstage products and therapy, for additional fluid removal.

• 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 ; 9786875276
• MDR Report Key: 7845429
• MDR Text Key: 119158519
• Report Number: 3003464075-2018-00034
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: K122051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/01/2005,09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NX1000-3
• Device Catalogue Number: NX1000-3
• Was Device Available for Evaluation?: No
• 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: 08/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR
• Patient Weight: 109