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 Air Embolism (1697); Cardiac Arrest (1762); Stroke/CVA (1770); Death (1802); Seizures (2063); Dizziness (2194); Brain Injury (2219)

Event Date 04/03/2020

Event Type  Death  

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.(b)(4).

Event Description

A report was received on 24 apr 2020 from the home therapy nurse (htn) regarding a (b)(6) year old female with an extensive medical history who became dizzy and unresponsive after troubleshooting alarms and terminating hemodialysis treatment with rinseback on (b)(6) 2020.911 was called and the patient was transported to hospital where she subsequently expired on (b)(6) 2020.Additional information was received 29 apr 2020 from the htn which showed resuscitation measures included intubation and epinephrine (route not specified).After arriving at the hospital the patient was admitted to the intensive care unit (icu).A ct scan revealed an air embolism in the brain.The hospital course involved the patient being mechanically ventilated for acute respiratory failure secondary to the anoxic brain injury and an acute bifrontal lobe embolic cerebrovascular accident (cva).The patient remained unresponsive and areflexic and was given a poor prognosis.Their condition worsened due to systemic inflammatory response syndrome, brain injury, acute encephalopathy and seizures.The patient was extubated on (b)(6) 2020, placed on comfort care and expired at 21:45hrs on (b)(6) 2020 with cardiac arrest reported as the cause of death.

Manufacturer Narrative

The device was received and evaluated and was found to be functioning as designed and intended.The log file for the treatment was analyzed and findings showed that at the time of the event the prime and alarm test was still in progress.During the prime and alarms test some safety systems, including air alarms, are inactive to allow the user to expel air from the extracorporeal circuit.The nxstage system one user guide warns to never connect the patient to the cartridge before you see the treatment parameters in the nxstage system one cycler¿s window, which indicates that the prime and alarms test is completed.There was no device malfunction.The available information is consistent with a use error and the diagnosis of air embolism provided by the physician.H3 other text : placeholder.

• Brand Name: NXSTAGE SYSTEM ONE
• Type of Device: HIGH PERMEABILITY HEMODIALYSIS SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack street; lawrence MA 01843
• MDR Report Key: 10083032
• MDR Text Key: 191836464
• Report Number: 3003464075-2020-00026
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: K050525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NX1000-1
• Device Catalogue Number: CYC-D2E W/ SERVICE COMPUTER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• 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: 04/24/2020
• Initial Date FDA Received: 05/22/2020
• Supplement Dates Manufacturer Received: 05/20/2020
• Supplement Dates FDA Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 40 YR
• Patient Weight: 56