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

Model Number NX1000-1

Device Problems Occlusion Within Device (1423); Device Displays Incorrect Message (2591)

Patient Problem Pulmonary Embolism (1498)

Event Date 10/11/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned for investigation, therefore; no product evaluation was possible.A review of the device history record revealed no similar issues.The device alarmed as designed to alert the user.The user guide states the risk of blood clotting in the cartridge and dialyzer is higher in certain patients who are prone to clotting.The user is warned to terminate treatment as soon as clotting is observed or suspected and to discard the cartridge and dialyzer.All available information supports that the product was functioning as designed and there was no malfunction.Nxstage medical considers this report closed.No additional information will be provided.

Event Description

Information was received on 1 dec 2017 regarding a (b)(6) female patient with multiple comorbidities including high risk conditions predisposing to clotting (absence of a spleen and super vena cava syndrome), who was receiving a standard home hemodialysis treatment on (b)(6) 2017 and experienced clotting within the first few minutes of treatment.The cycler alarmed as designed to alert the user to the issue.The nurse elected to manually evacuate the clot from the line and perform rinseback.The patient was hospitalized two days later, on (b)(6) 2017 with an admitting diagnosis of bilateral pulmonary embolism (bpe).The patient was released from the hospital on (b)(6) 2017.No additional information was 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 ; 9786874700
• MDR Report Key: 7135759
• MDR Text Key: 95415096
• Report Number: 3003464075-2017-00057
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• 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: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NX1000-1
• Device Catalogue Number: CYC-D2E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2014
• 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: 33 YR
• Patient Weight: 66