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

Model Number RFP-209

Device Problem Insufficient Information (3190)

Patient Problem Liver Damage/Dysfunction (1954)

Event Date 05/04/2018

Event Type  Injury  

Manufacturer Narrative

The available information does not indicate a device malfunction.No serial number or lot numbers were provided and no product has been received for evaluation.A review of the device history record (dhr) could not be performed.The nxstage system one user guide states "physicians should take extra care when prescribing dialysate for patients with an increased level or an impaired metabolism of lactate ions, as in severe hepatic insufficiency." nxstage medical considers this report closed.No additional information will be provided.

Event Description

A report was received on 12 jun 2018 from a physician stating that a (b)(6) patient with unspecified comorbidities who commenced hemodialysis using the nxstage device on (b)(6) 2018, developed hepatic cytolysis with elevated liver enzymes on (b)(6) 2018.Additional information received from the facility on 15 jun 2018 revealed the patient did not experience symptoms and no medical intervention was required.Dialysis treatments with the nxstage system were discontinued on (b)(6) 2018 and hemodialysis treatments using a device from another manufacturer were commenced on (b)(6) 2018 with improvement in liver enzymes on (b)(6) 2018.

• 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: 7625354
• MDR Text Key: 111889895
• Report Number: 3003464075-2018-00027
• Device Sequence Number: 1
• Product Code: KPO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K033386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: RFP-209
• Device Catalogue Number: RFP-209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 61 YR
• Patient Weight: 48