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

Model Number NX1000-1

Device Problem Use of Device Problem (1670)

Patient Problems Anemia (1706); Low Blood Pressure/ Hypotension (1914)

Event Date 08/21/2017

Event Type  Injury  

Manufacturer Narrative

There is no information to indicate that a device malfunction occurred.The available information supports that the device alarmed appropriately and performed as designed and intended.The nxstage system one user guide provides information for troubleshooting alarms and performing rinseback in the event alarms cannot be resolved.The device has not been received for evaluation and no serial number was provided, therefore a device history record (dhr) review could not be performed.Nxstage medical considers this report closed.No additional information will be provided.

Event Description

A report was received on (b)(6) 2017 regarding a (b)(6) female who felt unwell while troubleshooting alarms during a standard home hemodialysis treatment and went to the hospital for evaluation.Additional information received from the home therapy nurse on august 28, 2017 revealed that the patient had experienced a hypotensive episode and stroke-like symptoms and she had remained in hospital from (b)(6) 2017.The htn stated that the patient had experienced 4 - 5 blood loss events (approx.190 ml each time) during the previous week due to use issues during troubleshooting which exacerbated her existing anemia and hypotension.Her epogen dosage was increased and hemodialysis treatment was performed while in hospital.No other medical intervention was required and she was discharged in stable condition on (b)(6) 2017.

• 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 ; 9786874700
• MDR Report Key: 6862579
• MDR Text Key: 86082755
• Report Number: 3003464075-2017-00043
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K050525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NX1000-1
• Device Catalogue Number: CYC-D2E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR
• Patient Weight: 47