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 Abdominal Pain (1685); Hemolysis (1886); High Blood Pressure/ Hypertension (1908); Vomiting (2144)

Event Date 12/22/2017

Event Type  Injury  

Manufacturer Narrative

The cycler and express fluid warmer were returned for evaluation and there was no malfunction. Both devices passed all testing and were found to perform as designed and intended. Log files were received and analyzed, and confirmed that the system performed as designed during treatment, with no indication of a causal relationship to the patient adverse event. A device history record (dhr) review for the cycler was conducted and revealed the product was released having met all design and acceptance requirements prior to release. A cartridge dhr review was performed and showed that the lot was released having met all quality and manufacturing specifications and requirements. Biocompatibility of the device has been established. An express fluid warmer dhr review was conducted and showed no defects during the manufacturing of the device. Although the available information supports that nxstage equipment and therapy was functioning as designed, a relationship between the device and the reported symptoms cannot be excluded. Nxstage medical considers this report closed. No additional information will be provided.

Event Description

A report was received on 22 dec 2017 regarding a (b)(6) female patient who developed symptoms of vomiting, abdominal pain and hypertension approximately two hours into a standard in-center hemodialysis treatment. Therapy was discontinued and the patient was admitted to the hospital on (b)(6) 2017 with suspected hemolysis. Treatment included administration of paracetamol and oramorph for pain relief, and 1650 units of intravenous dalteparin prior to discharge on (b)(6) 2017. Although requested no discharge diagnosis was provided. The patient was changed to a dialyzer from a different manufacturer and continues to treat with the nxstage system one.

• 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: 7193556
• MDR Text Key: 97328786
• Report Number: 3003464075-2018-00002
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K050525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: NX1000-1
• Device Catalogue Number: CYC-D2E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 01/16/2018 Patient Sequence Number: 1

Treatment

CORDIAX FX60