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

Model Number NX1000-16-A

Device Problems Entrapment of Device (1212); Fluid Leak (1250); Device Dislodged or Dislocated (2923)

Patient Problems Death (1802); Blood Loss (2597)

Event Date 10/27/2020

Event Type  Death  

Manufacturer Narrative

A review of the device history record (dhr) was conducted which confirmed that the device met all quality criteria and manufacturing specifications prior to release. A review of the complaint database revealed no other events of this nature for the reported device serial number. The device was requested for return. The clinic confirmed the device is being held as part of an open investigation and is not available for return. There was no indication of a device malfunction from the available information. (b)(4).

Event Description

A report was received on 28 oct 2020 from the (b)(6) of a (b)(6) year old male patient with a medical history of end stage renal disease approved for solo use stating the patient expired during a hemodialysis treatment on (b)(6) 2020. Additional information was received on 03 nov 2020 from the (b)(6) who stated that the heparin line was not clamped and the patient experienced a blood leak during treatment. At an unspecified time, the patient transferred into his wheelchair and began to move toward the bathroom. Per the reporter, the patient¿s access line was caught in the left wheel of the chair causing both needles to dislodge from his arm. Per the htn the cause of death has not been determined.

• 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: 10884771
• MDR Text Key: 217674724
• Report Number: 3003464075-2020-00075
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K170469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: Yes

Device Operator

• Device Model Number: NX1000-16-A
• Device Catalogue Number: CYCLER VERSIHD 1.0 NO NIBP MOD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 11/23/2020 Patient Sequence Number: 1