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

Model Number CAR-172-C

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

Patient Problems Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Test Result (2695); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There is no indication of a device malfunction. The product meets all quality criteria and manufacturing specifications prior to release and biocompatibility of the device has been established. The user guide states that a decrease in platelet count is a potential risk associated with dialysis therapy and monitoring of the patient should be performed regularly to ensure an appropriate response to therapy.

Event Description

A report was received on (b)(6) 2019 from a healthcare professional regarding a (b)(6) female with a medical history significant for chronic renal failure due to iga nephropathy, previous failed renal transplant, elevated von willebrand factors and hemorrhagic events including post surgical hemorrhage and transfusion, epistaxis and menorrhagia who experienced a decrease in platelets and idiopathic thrombocytopenic purpura while using the nxstage system on an unspecified date. Additional information received on 30 sep 2019 from the healthcare professional stated the patient had no additional symptoms or medical intervention.

• 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 ; 9784505276
• MDR Report Key: 9158552
• MDR Text Key: 163360472
• Report Number: 3003464075-2019-00053
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K140526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/01/2005,10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Event Location: No Information
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 10/04/2019 Patient Sequence Number: 1