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

Model Number NX1000-3

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

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

Event Date 05/29/2020

Event Type  Death  

Manufacturer Narrative

The involved cycler has not been received for evaluation.A review of the device history record (dhr) was conducted which confirmed 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 07 jun 2020 from the nurse of a (b)(6) year old male patient with a medical history of end stage renal disease, diabetes, and recent illness (nos) accompanied by fever, approved for performing solo home hemodialysis treatments, stating the patient was found laying on the floor and unresponsive while partially connected to the nxstage cycler on (b)(6) 2020.An unspecified amount of blood surrounded the patient and it was observed that only one bloodline (nos) was connected to the patient¿s central venous catheter (cvc) at the time of being found.Per the report, treatment began at 2223 on the night of (b)(6) 2020 and completed at 0348 on the morning of (b)(6) 2020.Treatment details, time of death, and cause of death were requested and have not been received.

Manufacturer Narrative

The cycler was received for evaluation and passed all testing with no trouble found.The log file for the treatment confirmed the device passed the prime and alarms test indicating proper functionality of the device and sensors.The treatment was unremarkable and completed without issue.All available information supports that the device was functioning as designed and intended with no malfunction or product deficiency.Udi #: (b)(4).

• 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: 10233989
• MDR Text Key: 197610940
• Report Number: 3003464075-2020-00037
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: K122051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NX1000-3
• Device Catalogue Number: CHRONIC HI-FLOW CYCLER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• 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: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 50 YR
• Patient Weight: 159