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

Model Number CAR-170-C

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

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

Event Date 11/12/2019

Event Type  Injury  

Manufacturer Narrative

There was no indication of a device malfunction.All product is released meeting all product design specifications and quality criteria.A device history review of the complaint database revealed no other events of this nature for the reported lot number.The instructions for use warns that the device must be used under the prescription of a physician.The user guide includes a decrease in platelet count as a potential risk associated with dialysis therapy and states monitoring of the patient should be performed regularly to ensure an appropriate response to therapy.

Event Description

A report was received on 03 dec 2019 from the home therapy nurse (htn) of a (b)(6) male with a medical history of end-stage renal disease, diabetes, and a recent history of admission to hospital for treatment of leg wounds unrelated to nxstage, stating the patient experienced a decrease in platelet count while using the nxstage system on (b)(6) 2019.Additional information was received on 05 dec 2019 from the htn stating the patient experienced bruising.There was no report of medical intervention and although requested, additional information has not been provided.

• 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: 9504685
• MDR Text Key: 173981861
• Report Number: 3003464075-2019-00082
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Public: +M535CAR170C0/$$122090777010+
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K140526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/01/2005,12/20/2019

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: 12/01/2020
• Device Model Number: CAR-170-C
• Device Catalogue Number: CAR-170-C
• Device Lot Number: 90777010
• 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: 12/03/2019
• Initial Date FDA Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR