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

Model Number NX1000-3-A

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

Patient Problems Loss of consciousness (2418); Loss Of Pulse (2562)

Event Date 03/26/2020

Event Type  Injury  

Manufacturer Narrative

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.There is no information to indicate that a malfunction occurred.(b)(4).

Event Description

A report was received on (b)(6) 2020 from the home therapy nurse (htn) regarding a (b)(6) female with a pacemaker and history of cardiac disease, who was treating without a caregiver present and was found unresponsive and pulseless at an unspecified time during a home hemodialysis treatment on (b)(6) 2020.Additional information was received (b)(6) 2020 from the home therapy nurse (htn) who stated emergency services were contacted, resuscitative measures were performed with return of spontaneous circulation and the patient was transported to hospital.Hospitalization included testing for covid-19 (negative) and intubation for approximately a week.After extubation, the patient was conscious, alert and oriented and remained in hospital as of (b)(6) 2020.

• 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: 9922246
• MDR Text Key: 186430122
• Report Number: 3003464075-2020-00022
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: K122051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/01/2005,04/03/2020

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-A
• Device Catalogue Number: NX1000-3-A
• 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: 03/26/2020
• Initial Date FDA Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Weight: 82