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

Model Number NX1000-3-A

Device Problem Disconnection (1171)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Loss of consciousness (2418); Blood Loss (2597)

Event Date 12/22/2020

Event Type  Death  

Manufacturer Narrative

The involved cycler 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.Needle dislodgement is a recognized risk of hemodialysis therapy.The nxstage system one user guide warns that access sites must be taped per the dialysis facility procedures and checked when the patient changes position, must remain visible throughout treatment and that a trained and qualified person must observe all treatments so that harmful conditions can be responded to promptly.Udi: (b)(4).

Event Description

A report was received on 24 dec 2020 from the home therapy nurse (htn) of a (b)(6) year old male with a bad heart condition including previous coronary artery bypass surgery (x5 grafts) and end stage renal disease, who stated the patient expired after experiencing blood loss (amount not provided) from dislodged needles on (b)(6) 2020.Additional information was received on 30 dec 2020 from the htn who stated the patient was approximately four hours into a six-hour treatment and the care partner was not present in the room, returning when the patient called for assistance.Per the nurse, the patient was in bed and dislodged the hemodialysis needles when turning over leading to an unspecified amount of blood loss, loss of consciousness and cardiopulmonary arrest.Emergency medical services were called and established return of spontaneous circulation followed by transport to hospital where two units of blood were given.While at the hospital the patient lost consciousness for a second time, was unable to be revived and subsequently expired on (b)(6) 2020, time not provided.

• 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: 11179795
• MDR Text Key: 227473022
• Report Number: 3003464075-2021-00001
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K122051
• 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: 01/15/2021

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: CHRONIC HI-FLOW CYCLER, ROHS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 89