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

Model Number SAK-302

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

Patient Problems Fever (1858); Sepsis (2067)

Event Date 02/12/2021

Event Type  Injury  

Manufacturer Narrative

The user stated that the device leaked due to compromised integrity of the dialysate sack.Per the htn, the involved product was discarded and was not available for evaluation.The nxstage user guide provides instructions and warnings to monitor for leaks, maintain aseptic technique and to prevent the risk of exposure to infectious diseases.All product is released meeting all quality criteria and manufacturing specifications.Biocompatibility of the device has been established.

Event Description

A report was received on 19 feb 2021 from the caregiver (cg) of a (b)(6) year old male patient with a medical history of glomerulonephritis and end stage renal disease, stating the patient experienced fever and was hospitalized following a hemodialysis treatment on (b)(6) 2021.Additional information was received on 22 feb 2021 from the home therapy nurse (htn) who stated the patient terminated treatment and was admitted to hospital with a diagnosis of sepsis on (b)(6) 2021.Blood cultures identified enterococcus gallinarum and no additional details of the hospitalization or treatment were provided.

• 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: nxstage medical, inc; 350 merrimack street; lawrence, MA 01843 ; 9784505276
• MDR Report Key: 11474137
• MDR Text Key: 239716657
• Report Number: 3003464075-2021-00010
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K140571
• Exemption Number: 5645646
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SAK-302
• Device Catalogue Number: SAK-302
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR