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

Model Number NX1000-1

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

Patient Problems Cardiac Arrest (1762); Death (1802); Loss of consciousness (2418)

Event Date 08/24/2017

Event Type  Death  

Manufacturer Narrative

The cycler was received for evaluation and found to be functioning as designed and intended.The device history record (dhr) for the cycler was reviewed and revealed that the product was released having met all product design and acceptance requirements prior to release.Review of the dhr for the involved cartridge was performed and no defects were found during the manufacturing of this lot.(b)(4).Nxstage medical considers this report closed.No additional information will be provided.This report and the information contained herein is submitted to the food & drug administration under 21 cfr part 803 and represents the information available to the company at the time of the report.

Event Description

A report was received on (b)(6) 2017 regarding a (b)(6) old male patient with significant comorbidities who experienced a cardiac event during a standard home hemodialysis treatment on (b)(6) 2017.Comorbidities included anemia, hypertension, atrial fibrillation, prostate cancer, type ii diabetes, hypercholestrolemia, secondary hyperparathyroidism, benign prostatic hypertrophy and left eye removal.Additional information received from the home therapy nurse on (b)(6) 2017 revealed that the patient was found unresponsive approximately 1 hour and 20 minutes into treatment.Emergency services were contacted and resuscitative efforts were commenced.The patient returned to a viable rhythm and was admitted to hospital.Later that evening the patient experienced a cardiac arrest and passed away.The family had requested no further life support or resuscitative efforts.

• 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 ; 9786874700
• MDR Report Key: 6870076
• MDR Text Key: 86359406
• Report Number: 3003464075-2017-00044
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Device Model Number: NX1000-1
• Device Catalogue Number: CYC-D2E W/ SERVICE COMPUTER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 67 YR
• Patient Weight: 117