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 Muscle Weakness (1967); Vomiting (2144); Electrolyte Imbalance (2196)

Event Date 09/06/2021

Event Type  Injury  

Manufacturer Narrative

The involved device was not received for evaluation.Available log files were retrieved and analyzed which showed the device was performing as designed and intended.A review of the device history record (dhr) was conducted which confirmed that the product met all quality criteria and manufacturing specifications prior to release.(b)(4).

Event Description

A report was received on (b)(6) 2021 from the home therapy nurse (htn) of a (b)(6) year old male patient with a medical history including diabetes and end stage renal disease, who stated the patient had been unable to complete his standard home hemodialysis treatment on (b)(6) 2021 and was admitted to the hospital with high potassium levels on (b)(6) 2021.Additional information was received on (b)(6) 2021 from the htn who stated the patient experienced generalized weakness and persistent vomiting following his treatment on (b)(6) 2021, presenting to the hospital the following morning with a potassium of 6.4 mmol/l.The patient was admitted on (b)(6) 2021, received emergency dialysis treatment (nos), and was discharged on (b)(6) 2021 with an in-range potassium level of 4.1mmol/l.Following the event the patient has recovered without sequelae, planning to resume treatment with nxstage therapy.

• 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
• MDR Report Key: 12553660
• MDR Text Key: 274006787
• Report Number: 3003464075-2021-00049
• 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: 09/30/2021

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
• Device Catalogue Number: CHRONIC HI-FLOW CYCLER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2021
• Initial Date FDA Received: 09/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2018
• Is the Device Single Use?: No
• 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: 66 YR
• Patient Weight: 143