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

Model Number NX1000-16

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Diarrhea (1811); No Code Available (3191)

Event Date 06/29/2020

Event Type  Injury  

Manufacturer Narrative

The involved cycler was not returned for evaluation and a serial number was not provided.All devices must meet quality requirements and manufacturing specifications prior to release.Factors outside the scope of nxstage therapy can impact the patient's weight, these include but are not limited to the accuracy with which intake is recorded, the weighing techniques used, and the patient's comorbidities.

Event Description

A report was received on 08 jul 2020 from a home therapy nurse (htn) regarding a (b)(6)year old female patient with end stage renal disease and unspecified congenital anomaly, stating an insufficient amount of fluid was removed during multiple home hemodialysis treatments (dates not specified) and the patient was hospitalized.Additional information was received on 10 jul 2020 from the htn stating the patient was admitted to hospital on (b)(6) 2020 with diarrhea, ¿stomach bug", and fluid retention.The patient received hemodialysis treatments while hospitalized and was discharged on (b)(6)2020.Although requested, other treatment details, the course of hospitalization, and the discharge diagnosis have not been received.

• 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: 10369859
• MDR Text Key: 207508192
• Report Number: 3003464075-2020-00044
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K170469
• 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: 01/01/2005,08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NX1000-16
• Device Catalogue Number: CYCLER VERSIHD, NO NIBP MODULE
• 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: 07/08/2020
• Initial Date FDA Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 34 YR
• Patient Weight: 55