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 Bruise/Contusion (1754); Test Result (2695)

Event Date 04/11/2019

Event Type  Injury  

Manufacturer Narrative

There was no indication of a device malfunction.A review of the device history record (dhr) was performed and revealed no related defects during the manufacturing process.The lot was released for distribution having met all product design requirements.The instructions for use warns that the device must be used under the prescription of a physician.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.Nxstage medical considers this report closed.No additional information will be provided.

Event Description

A report was received on 17 apr 2019 from the nurse regarding a (b)(6) female with a history of (b)(6), who experienced platelet decreases after using the nxstage system one to perform hemodialysis therapy on multiple, unspecified dates.Additional information was received on 23 apr 2019 from the nurse stating the patient did not experience any additional symptoms and no medical intervention was required.Follow up information was received on 20 may 2019 from the physician which revealed the patient experienced generalized bruising in association with their decreased platelets.The patient changed to a system from a different manufacturer (nos) and has recovered.

• 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: 8649306
• MDR Text Key: 146355785
• Report Number: 3003464075-2019-00016
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: M535CAR172C0
• UDI-Public: +M535CAR172C0/$$062080977027C
• Combination Product (y/n): Y
• Reporter Country Code: EZ
• PMA/PMN Number: K140526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2020
• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Device Lot Number: 80977027
• 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
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR