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 08/20/2019

Event Type  Injury  

Manufacturer Narrative

A review of the device history record (dhr) was conducted which confirmed the device was released meeting all quality requirements and manufacturing specifications.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 06 sep 2019 from a healthcare professional (hcp) via the distributor, stating a (b)(6) male had experienced a decrease in platelet count with no report of symptoms after treating with the nxstage system on (b)(6) 2019.Follow up information was received on 19 sep 2019 from the hcp stating the patient experienced bruising on (b)(6) 2019.The patient changed to a dialyzer from a different manufacturer and platelet count increased.No medical intervention was required.

• 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: 9124158
• MDR Text Key: 165956445
• Report Number: 3003464075-2019-00050
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: M535CAR172C0
• UDI-Public: +M535CAR172C0/$$1020901770281
• Combination Product (y/n): Y
• Reporter Country Code: SW
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/01/2005,09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2020
• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Device Lot Number: 90177028
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 53