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

Model Number NX1000-1

Device Problems Improper or Incorrect Procedure or Method (2017); Connection Problem (2900)

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

Event Date 10/29/2019

Event Type  Death  

Manufacturer Narrative

The involved device was not received for evaluation.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.The nxstage system one user guide (supplement for solo home hemodialysis) states that all treatments must be administered under physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.A trained and qualified patient may dialyze alone, provided the patient and his or her physician agree that solo home hemodialysis is appropriate.Additional ancillary devices and training are required when performing solo home hemodialysis.The user guide warns that certain risks associated with hemodialysis treatment may increase when therapy is performed without a care partner.These risks may include, but are not limited to, blood loss leading to death during treatment.Udi #: (b)(4).

Event Description

A report was received on 27 nov 2019 from a home therapy nurse (htn), regarding the discontinuation of an (b)(6) year old male trained and approved for performing solo home hemodialysis treatments with the nxstage system.Additional information was received on 14 jan 2020 from the htn stating the patient had expired during hemodialysis therapy while connected to the device due to a use error.Per the htn, the patient disconnected the bloodline to adjust his access needles early in treatment and made erroneous connections when reconnecting to continue therapy, resulting in approximately 2l of blood loss into the saline bag.A person unfamiliar with hemodialysis and present at the time of the event noted the patient looked unwell and contacted emergency services who pronounced the patient deceased upon their arrival.Per the htn, there was no device malfunction and the reported event is related to a use error, unrelated to nxstage product and 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 ; 9784505276
• MDR Report Key: 9667358
• MDR Text Key: 177668598
• Report Number: 3003464075-2020-00008
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• 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
• Report Date: 01/01/2005,02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NX1000-1
• Device Catalogue Number: NXSTAGE SYSTEM ONE
• 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
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 82 YR