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 Cardiopulmonary Arrest (1765); Loss of consciousness (2418)

Event Date 09/26/2017

Event Type  Death  

Manufacturer Narrative

The device has not been received for evaluation.The device history record (dhr) was reviewed for both the cycler and pureflow sl devices and revealed no related issues in servicing or manufacturer for these units.The cartridge dhr was also reviewed which showed there were no related quality issues during the manufacturing of this lot.

Event Description

A report was received on (b)(6) 2017 regarding a (b)(6) female patient who felt faint, lost consciousness and coded approximately 10 minutes into a standard hemodialysis treatment.Cpr was initiated and the patient was transferred to the hospital.Additional information received from the patient's nurse revealed that the patient was admitted to the hospital the same day and remains hospitalized.No further information has been provided.

Manufacturer Narrative

Information was received on (b)(6) 2017 from the patient's nurse indicating that the patient expired on (b)(6) 2017.Although requested, additional information has not been provided.No further information is available.

• 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: 6891715
• MDR Text Key: 87321189
• Report Number: 3003464075-2017-00046
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NX1000-1
• Device Catalogue Number: CYC-D2E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2017
• Initial Date FDA Received: 09/25/2017
• Supplement Dates Manufacturer Received: 09/01/2017
• Supplement Dates FDA Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 66 YR
• Patient Weight: 108