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

Model Number NX1000-3-A

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

Patient Problems Dyspnea (1816); Swelling (2091)

Event Date 12/30/2019

Event Type  Injury  

Manufacturer Narrative

The device was not received for evaluation.A review of the device history record confirmed the product was released meeting all quality criteria and manufacturing specifications.Udi: (b)(4).

Event Description

A report was received on 14 jan 2020 from the home therapy nurse (htn) regarding a (b)(6) female patient with a prior medical history significant for congestive heart failure, hypertension, anemia, right lung lower lobe malignancy and resection of same, rejection of renal transplant and postpartum cardiomyopathy, who removed insufficient fluid during home hemodialysis treatments and presented to the hospital on (b)(6) 2019.Additional information was received on 15 jan 2020 from the htn which revealed the patient experienced shortness of breath, cough and leg swelling on admission to hospital.Treatment in hospital included dialysis treatments and changes to antihypertensives and diuretics.Symptoms improved and the patient was released from hospital on (b)(6) 2020 in stable condition to continue dialysis therapy with the nxstage system one.

• 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: 9646511
• MDR Text Key: 177642939
• Report Number: 3003464075-2020-00005
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K122051
• 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: 01/01/2005,01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NX1000-3-A
• Device Catalogue Number: CHRONIC HI-FLOW CYCLER, ROHS
• 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
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR